Z-1276-2024Class II

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile

Name: Z-1276-2024 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile
Creator: ConvaTec, Inc
Published: 2024-01-17
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2024-01-17 / Open, Classified / root cause: labeling and UDI

FDA source

ConvaTec, Inc began a recall of ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile on 2024-01-17. FDA classified it as Class II and gives the reason as "The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1276-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-17
Posted: 2024-09-30
Recalling firm: ConvaTec Limited
Product: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Product code: FON Bag, Drainage, With Adhesive, Ostomy
Reason for recall: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 1,715 units
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 codes and lots: Lot #2C02496, UDI-DI #00768455116096.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1276-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07

Product code FON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)