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Dermatology

This page shows you the most recent publications within this specialty of the MedWorm directory.

Customed, Inc - Class 1 Recall
NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) CUP MEDICINE 2oz UF (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL (20) GAUZE SPONGE 4" X 4" 16ply XRD UF (5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF (1) YANKAUER SUCT. TUBE W/0 VENT LIF (1) DRAPE INCISE ANTIMICRO...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCT...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SM...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID ...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 ...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60" X 76" REINFORCED L/F (1) DRAPE CHEST 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. Y." X 12' UF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X ...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50" X 90"...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Enhancement Medical, LLC - Enhancement Medical expression - Class 1 Recall
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2014 Category: Medical Equipment Source Type: alerts

Ra Medical Systems Inc - PHAROS Excimer Laser - Class 2 Recall
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 29, 2014 Category: Medical Equipment Source Type: alerts

Laser Peripherals LLC - DBLF602 Bare Laser fiber - Class 2 Recall
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 18, 2014 Category: Medical Equipment Source Type: alerts

Solta Medical, Inc. - Fraxel Laser System - Class 2 Recall
FRAXEL DUAL 1550/1927 Laser System (FRAXEL SR 1500 DUAL Laser System) Product Usage: Used for dermatological procedures requiring coagulation of soft tissue as well as for skin resurfacing, treatment of Actinic keratosis and treatment of pigmented lesions such as but not limited to Lentigos (age Spots), solar lentigos (sun spots) and, ephelides (freckles) and melasma and treatment of periorbital wrinkles, acne scars and surgical scars. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2014 Category: Medical Equipment Source Type: alerts

Candela Corporation - Candela Laser - Class 2 Recall
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2013 Category: Medical Equipment Source Type: alerts

Convergent Dental - Solea 1.0 - Class 2 Recall
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2013 Category: Medical Equipment Source Type: alerts

National Biological Corp - Dermalight 80, UVB083 - Class 3 Recall
Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2013 Category: Medical Equipment Source Type: alerts

National Biological Corp - Dermalight 80. UVB080 - Class 3 Recall
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2013 Category: Medical Equipment Source Type: alerts

ConBio, a CynoSure Company - RevLite SI Laser - Class 2 Recall
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2013 Category: Medical Equipment Source Type: alerts

Zimmer Surgical Inc - Air Dermatome - Class 2 Recall
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Zimmer Surgical Inc - Air Dermatome II - Class 2 Recall
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Zimmer Surgical Inc - Air Dermatome II - Class 2 Recall
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Oculus Innovative Sciences Inc - Atrapro Antipruritic Hydrogel, 1.5 oz gel tube - Class 2 Recall
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Healthtronics, Inc. - HealthTronics Endocare 3.8mm RenalCryo Cryoprobe - Class 2 Recall
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery, (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2013 Category: Medical Equipment Source Type: alerts

Quanta System, S.p.A. - QPlus T Powered Laser Surgical Instrument - Class 2 Recall
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

Quanta System, S.p.A. - Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser - Class 2 Recall
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or perma...
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

Quanta System, S.p.A. - Eterna Giovinezza System - Class 2 Recall
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

OmniGuide, Inc. - OmniGuide BPROBOTIC - Class 2 Recall
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colon...
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall
Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesion...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Oculus Innovative Sciences Inc - Microcyn Dermatology Spray - Class 2 Recall
Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care...
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Oculus Innovative Sciences Inc - Microcyn Dermatology HydroGel Spray - Class 2 Recall
Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulc...
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Genesis Manufacturing Inc - ActiveCare DVT - Class 2 Recall
ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Genesis Manufacturing Inc - ActiveCare SFT - Class 2 Recall
ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Teleflex Medical - DermaHood Neuro Elastic Retractors - Class 2 Recall
Weck, DermaHook ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Medical Compression Systems - ActiveCare SFT - Class 2 Recall
ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Medical Compression Systems - ActiveCare DVT - Class 2 Recall
ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2012 Category: Medical Equipment Source Type: alerts

Synthes USA (HQ), Inc. - Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive - Class 2 Recall
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2011 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. - Padgett Dermatome power supply units - Class 2 Recall
Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2011 Category: Medical Equipment Source Type: alerts

Davol, Inc., Sub. C. R. Bard, Inc. - XenMatrix Surgical Graft - Class 1 Recall
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 1161520 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Davol, Inc., Sub. C. R. Bard, Inc. - XenMatrix Surgical Graft - Class 1 Recall
XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Davol, Inc., Sub. C. R. Bard, Inc. - XenMatrix Surgical Graft - Class 1 Recall
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Davol, Inc., Sub. C. R. Bard, Inc. - XenMatrix Surgical Graft - Class 1 Recall
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Ethicon, Inc. - Dermabond Topical Skin Adhesive - Class 2 Recall
High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Ethicon, Inc. - Dermabond Topical Skin Adhesive - Class 2 Recall
Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2011 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - SeedNet Cryosurgiclal system - Class 2 Recall
SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The modified SeedNet is indicated for use as...
Source: Medical Device Recalls - February 4, 2011 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - Presice Cryosurgiclal system - Class 2 Recall
Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is indicated for use as a cryosurgical tool in the fi...
Source: Medical Device Recalls - February 4, 2011 Category: Medical Equipment Source Type: alerts

Solta Medical, Inc. - Fraxel re:store Dual Laser System - Class 2 Recall
Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2011 Category: Medical Equipment Source Type: alerts

FDA Cracks Down on Spa and Beauty Device Maker
WASHINGTON (MedPage Today) -- The FDA has announced a consent decree with medical device manufacturer Sybaritic that requires the company to cease production and distribution of laser surgery, dermatological, and spa devices until it complies with the agency's quality standards. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - January 11, 2010 Category: Drugs & Pharmacology Source Type: alerts

Linvatec Corp. dba ConMed Linvatec - ULTRAPOWER DIAMOND WHEEL Burs - Class 2 Recall
ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33...
Source: Medical Device Recalls since July 07, 2006 - September 9, 2009 Category: Medical Equipment Source Type: alerts

Sybaritic, Inc - NANNOLIGHT INTENSE PULSED LIGHT SYSTEM - Class 2 Recall
Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt...
Source: Medical Device Recalls since July 07, 2006 - September 4, 2009 Category: Medical Equipment Source Type: alerts

Ansell Healthcare Products LLC - DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) - Class 2 Recall
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - July 25, 2009 Category: Medical Equipment Source Type: alerts

Ansell Healthcare Products LLC - DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) - Class 2 Recall
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - July 25, 2009 Category: Medical Equipment Source Type: alerts