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    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KNT·April 29, 2014

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FON·February 19, 2024

    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    FDA Recall
    Open, Classified ·T.G. Eakin Limited·Product code EXE·August 8, 2024

    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

    FDA Recall
    Terminated ·Convatec Inc.·Product code EZQ·September 17, 2010

    Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc contains 10 units; Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558 Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.

    FDA Recall
    Terminated ·ConvaTec·Product code OMP·July 29, 2009

    Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558. Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.

    FDA Recall
    Terminated ·ConvaTec·Product code OMP·July 29, 2009

    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

    Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy

    FDA Recall
    Terminated ·Convatec Inc.·Product code OMP·July 9, 2010

    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FPD·January 9, 2019

    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code HTD·January 9, 2019

    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FON·February 16, 2026

    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code EZQ·August 16, 2022

    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code EZQ·August 16, 2022

    Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code EXE·September 6, 2019