Facility

ConvaTec Limited, GDC Building

20 recall(s) on record — most severe on record: Class II.

Key facts

20recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008806809
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	First Avenue Deeside Flintshire, GB CH5 2NU
Registration status	Active · expires 2026
Parent company	ConvaTec (owner-operator 2241599)
Brand names	Silicone Coated Catheter

Activity by year

Recalls (20)
Inspections (2)

Devices registered here (1)

Catheter, Urological
Product code KOD (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5130

Recalls & enforcement

20263 records

Class IIOngoing2026-07-06
Urostomy Pouches may leak from cap during use.
Class IIOngoing2026-06-08
Surgical dressing manufactured out of specification (greater thickness).
Class IIOngoing2026-02-16
Drainable large pouch may leak due to manufacturing issue.

20251 record

Class IIOngoing2025-08-29
Wound dressing may have foreign matter on the product.

20244 records

Class IIOngoing2024-11-29
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…
Class IIOngoing2024-02-27
The product does not meet sterility assurance level.
Class IIOngoing2024-02-19
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 IIOngoing2024-01-17
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

20223 records

Class IIOngoing2022-11-15
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 IIOngoing2022-08-16
impaired functionality of the release liner
Class IITerminated2022-04-22
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

20212 records

Class IIOngoing2021-08-20
Primary packaging labeling may be incorrect.
Class IIOngoing2021-08-09
There is a potential for open seals which can compromise sterility.

20192 records

Class IITerminated2019-09-06
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 IIOngoing2019-01-09
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

20182 records

Class IITerminated2018-07-03
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
Class IITerminated2018-04-25
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.

20172 records

Class IITerminated2017-10-26
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
Class IITerminated2017-05-10

20151 record

Class IITerminated2015-11-11
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

FDA inspections (2)

NAI2018-10-22
No Action Indicated · Compliance: Devices
VAI2016-08-17
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ConvaTec Limited, GDC Building (FEI 3008806809) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008806809-convatec-limited-gdc-building/

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