ConvaTec, Inc ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Brand
ConvaTec, Inc
Lot Codes / Batch Numbers
Lot #2C02496, UDI-DI #00768455116096.
Products Sold
Lot #2C02496, UDI-DI #00768455116096.
ConvaTec, Inc is recalling ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Ste due to The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Recommended Action
Per FDA guidance
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 us.customerservice@convatec.com or phone 800-582-6514.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX
Page updated: Jan 10, 2026