ConvaTec Limited
Deeside Flintshire, GB
CONVATEC LIMITED appears in FDA device records in Deeside Flintshire, GB. FDA records list 29 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 72 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for ConvaTec Limited between 1997 and 2026. The busiest year on record is 2018, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | EZD | Substantially Equivalent | |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | EZD | Substantially Equivalent | |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | EZD | Substantially Equivalent | |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | FCM | Unknown | |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | KNT | Substantially Equivalent | |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | EZD | Substantially Equivalent | |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | EZD | Unknown | |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | EZD | Substantially Equivalent | |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | GBM | Substantially Equivalent | |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | Substantially Equivalent | |
| K180205 | AVELLE Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | GBM | Substantially Equivalent | |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | FRO | Substantially Equivalent | |
| K172924 | GentleCath Intermittent Urinary Catheter | KOD | Substantially Equivalent | |
| K162906 | Flexi-Seal PROTECT Fecal Management System | KNT | Substantially Equivalent | |
| K161344 | GentleCath Glide Intermittent Catheter | KOD | Substantially Equivalent | |
| K152926 | AQUACEL Ag Surgical SP Dressing | FRO | Substantially Equivalent | |
| K150350 | Flexi-Seal Signal Fecal Management System | KNT | Substantially Equivalent | |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | KOD | Substantially Equivalent | |
| K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE | FRO | Substantially Equivalent | |
| K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER | FRO | Substantially Equivalent | |
| K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM | KNT | Substantially Equivalent | |
| K111365 | VITALA CONTINENCE CONTROL DEVICE | EZQ | Substantially Equivalent | |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | EZQ | Substantially Equivalent | |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | EZQ | Substantially Equivalent | |
| K091034 | AQUACEL AG SURGICAL | FRO | Substantially Equivalent | |
| K071763 | AMADEUS ADAPTIVE COMPRESSION THERAPY | JOW | Substantially Equivalent | |
| K973689 | DUODERM HYDROACTIVE DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K973688 | DUODERM CONTROL GEL FORMULA BORDER DRESSING | FRO | Substantially Equivalent for Some Indications |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000317571 | 1000317571 | CONVATEC LIMITED | First Avenue, Deeside Flintshire CH5 2NU GB | 2026 | and 10 more, listed in full below |
| 3011987967 | 3011987967 | ConvaTec, Inc. | 7815 National Service Road, Greensboro, NC 27409 US | 2026 | and 60 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- EZSAppliance, Colostomy, Disposable
- FONBag, Drainage, With Adhesive, Ostomy
- BTCBag, Reservoir
- EXHBag, Urinary, Ileostomy
- EXGBag, Urine Collecting, Ureterostomy
- FQMBandage, Elastic
- KMFBandage, Liquid
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- BZBCatheter, Nasal, Oxygen
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- GBMCatheter, Urethral
- BSYCatheters, Suction, Tracheobronchial
- EZRCement, Stomal Appliance, Ostomy
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- FKCClamp, Cannula
- EXBCollector, Ostomy
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- GCDConnector, Catheter
- FENDevice, Cystometric, Hydraulic
- KMKDevice, Intravascular Catheter Securement
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- BYHDrain, Tee (Water Trap)
- FRODressing, Wound, Drug
- FFDEvacuator, Bladder, Manually Operated
- FRLFiber, Medical, Absorbent
- CAHFilter, Bacterial, Breathing-Circuit
- HTDForceps
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- KDCInstrument, Surgical, Disposable
- EXDIrrigator, Ostomy
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- KGBMask, Oxygen, Non-Rebreathing
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- EZQPouch, Colostomy
- EXEProtector, Ostomy
- EZPRod, Colostomy
- FPASet, Administration, Intravascular
- BZOSet, Tubing And Support, Ventilator (W Harness)
- JOWSleeve, Limb, Compressible
- BSRStylet, Tracheal Tube
- KGXTape And Bandage, Adhesive
- BXOTransducer, Gas Pressure
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- JOHTube Tracheostomy And Tube Cuff
- FPDTube, Feeding
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
- EXRUrinometer, Mechanical
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
Showing 25 of 72| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2986-2026 | Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727. | Urostomy Pouches may leak from cap during use. | Class II | Open, Classified | |
| Z-2677-2026 | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | Surgical dressing manufactured out of specification (greater thickness). | Class II | Open, Classified | |
| Z-1584-2026 | Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | Open, Classified | |
| Z-1583-2026 | Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | Open, Classified | |
| Z-1582-2026 | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm | Drainable large pouch may leak due to manufacturing issue. | Class II | Open, Classified | |
| Z-0160-2026 | DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings. | Wound dressing may have foreign matter on the product. | Class II | Open, Classified | |
| Z-0903-2025 | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479 | Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding | Class II | Open, Classified | |
| Z-1495-2024 | ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit. | The product does not meet sterility assurance level. | Class II | Open, Classified | |
| Z-1350-2024 | 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 | Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld. | Class II | Open, Classified | |
| Z-1276-2024 | ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. | Class II | Open, Classified | |
| Z-0723-2023 | ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive | ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings. | Class II | Open, Classified | |
| Z-0130-2023 | 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. | impaired functionality of the release liner | Class II | Open, Classified | |
| Z-0129-2023 | 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. | impaired functionality of the release liner | Class II | Open, Classified | |
| Z-0128-2023 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure. | impaired functionality of the release liner | Class II | Open, Classified | |
| Z-0127-2023 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure. | impaired functionality of the release liner | Class II | Open, Classified | |
| Z-1134-2022 | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. | Class II | Terminated | |
| Z-2614-2021 | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | Primary packaging labeling may be incorrect. | Class II | Open, Classified | |
| Z-2519-2021 | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) | There is a potential for open seals which can compromise sterility. | Class II | Open, Classified | |
| Z-0233-2020 | 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 | ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring. | Class II | Terminated | |
| Z-1038-2019 | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering. | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1037-2019 | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs). | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1036-2019 | 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. | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1035-2019 | 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. | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2744-2018 | 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. | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. | Class II | Terminated | |
| Z-1890-2018 | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output. | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain