BEUDAMED
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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 Enforcement
    Class I ·Terminated·Convatec Inc.·June 25, 2014

    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

    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

    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

    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

    Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM

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

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code FEN·July 3, 2018

    Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 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

    SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: 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

    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KNT·June 25, 2013

    Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106

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