Class 2 Device Recall ConvaTec Natura

• Date Initiated by Firm: January 17, 2024
• Date Posted: September 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1276-2024
• Recall Event ID: 93896
• Product Classification: Bag, drainage, with adhesive, ostomy - Product Code FON
• Product: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
• Code Information: Lot #2C02496, UDI-DI #00768455116096.
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7815 National Service Rd Ste 600; Greensboro NC 27409-9403
• Manufacturer 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.
• FDA Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.