SUR-FIT NATURA recallZ-1276-2024 · ConvaTec, Inc · initiated Jan 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
FDA root cause category: Labeling Change Control
What the company is doing
The recalling firm issued letters dated Jan-2024 via email on 1/17/2024. The letter explained the issue, contained an embedded photo of the label for ease in identifying the product, and requested the consignee immediately examine their inventory and quarantine the affected product. If the consignee has further distributed the affected product, they are requested to notify them at once of the recall. A response form was enclosed for completion and return as soon as possible or within 30 days of receipt. A section of the letter listed the consignee's responsibilities. The responsibilities were: (1) Review this notification and ensure that all relevant stakeholders are aware of this recall communication; (2) Immediately locate and quarantine affected product in your inventory; (3) Complete APPENDIX 1 (Response Form) and return to Convatec as soon as possible or within 30 calendar days of receipt; (4) A review of the information you provide in accordance with APPENDIX 1 will be completed; (5) If the information from Step 4 is satisfactory, formal authorization from a Convatec Representative to proceed with product destruction will be provided; (6) Convatec will provide you with a Certificate of Destruction (COD) to complete; (7) Immediately destroy all affected product and provide Convatec with a signed Certificate of Destruction (COD) as evidence to support reconciliation and regulatory reporting; (8) Your account will be credited for all destroyed product upon receipt of a signed form as per APPENDIX 1 and a Certificate of Destruction (COD); and (9) If you are in receipt of this recall communication and are still unsure how to proceed, please contact Convatec via [email protected] or phone 800-582-6514.
Recall details
- Recall number
- Z-1276-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 17, 2024
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- ConvaTec, Inc
- Quantity
- 1,715 units
- Product code
- FON
- Distribution
- Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.
Product description
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Code information (models, lots, serial numbers)
Lot #2C02496, UDI-DI #00768455116096.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SUR-FIT NATURA 416938Convatec, Purchasing Department · Bag, Drainage, With Adhesive, Ostomy1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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