142 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
FDA Recall
Terminated
·Safe N Simple, LLC·Product code NEC·June 18, 2012
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***SKIN-PREP Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Helps tape, film and appliance adhesion Reduces friction Pediatrician tested***1 wipe***For external use only. Do not use with electrocautery procedures. Sting will be experienced if contacts cut or open wound. INGREDIENTS: Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. ------------------- Brand: SKIN-PREP Protective Wipes Bulk Case:***smith&nephew***SKIN-PREP Wipes BULK*** REF 420471 QTY 1000 Wipes ***. ------------------- Brand: SKIN-PREP CE Protective Wipes - Pouch Label: ***smith&nephew*** #59420425***SKIN-PREP***Box Label: ***smith&nephew***#59420425 SKIN-PREP 50***Carton Label: smith&nephew Wipes For International Export ***Quantity 20 Cartons of 50 REF #59420425***. ------------------ Brand: PERI-PREP CE Protective Wipes - Pouch Label and Box Label: ***Peri-Prep Peristomal Protective Dressing Wipe Product Code 840001 FOR ***SALTS HEALTHCARE***WARNINGS: Use only as directed. For external use only. do not apply to open wounds or mucus membrane. Avoid contact with eyes. Vapor may be harmful - use with adequate ventilation. Do no use with electrocautery procedures. FLAMMABLE: Do not use near heat, sparks or open flame. Keep out of reach of children. Seek medical advice before use on neonates. FIRST AID TREATMENT: If swallowed, give victim milk or water and induce vomiting. Call physician or poison control center immediately. If inhaled, remove to fresh air. If not breathing give artifical respiration, call physician. In case of contact with eyes, flush with water for 15 minutes including under eyelids. INGREDIENTS; Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. Brand: PERI-PREP CE - Case Label: ***smith&nephew Wipes Re-order #84001 ***PERI-PREP CE FLAMMABLE*** Quantity 20 Cartons of 50 REF #5132***. --------------- The following brand name products are manufactured using the same formulation . 1) SKIN-PREP Protective Wipes 50/Box Formulation F-06, Product Code 420400. 2) SKIN-PREP Protective Wipes Bulk Case 1000/Case Formulation F-06, Product Code 420471. [1000 individual wipes in a poly bag placed into a shipping carton.] 3) SKIN-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 59420425. 4) PERI-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 5132. Product Usage: Alcohol based liquid film-forming skin preparations that, upon application to intact skin, form a protective film to help reduce friction during removal of tapes and films. Skin-Prep can also be used to prepare skin attachment sites for drainage tubes, external catheters, surround ostomy sites and adhesive dressings.
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code NEC·April 4, 2011
Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code NEC·August 30, 2018
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
FDA Recall
Terminated
·Natus Medical Inc·Product code ETY·June 27, 2005
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
FDA Enforcement
Class II
·Terminated·GE Healthcare·March 25, 2015
V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
FDA Recall
Terminated
·Neo Medical, Inc.·Product code LRS·April 5, 2011
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Recall
Terminated
·NEO METRICS, INC.·Product code OCY·March 31, 2014
A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.
FDA Recall
Terminated
·A-Dec Inc·Product code KLC·April 1, 2009
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Recall
Terminated
·New Era Orthopaedics, LLc·Product code MNI·February 13, 2017
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
FDA Recall
Terminated
·New Star Lasers, Inc.·Product code GEX·September 19, 2016
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
FDA Recall
Terminated
·New Star Lasers, Inc.·Product code GEX·September 19, 2016
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
FDA Recall
Terminated
·New Star Lasers, Inc.·Product code GEX·May 13, 2015
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas
FDA Recall
Terminated
·New Star Lasers, Inc.·Product code GEX·September 19, 2016