FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
- Recall number
- Z-1276-2024
- Recalling firm
- ConvaTec, Inc
- Product
- ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
- Status
- Open, Classified
- Initiated
- 2024-01-17
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- 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
- 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 us.customerservice@convatec.com or phone 800-582-6514.
- Quantity
- 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.
- Lot, serial or model codes
- Lot #2C02496, UDI-DI #00768455116096.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FON
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28