Class 2 Device Recall SURFIT Natura

• Date Initiated by Firm: April 22, 2022
• Create Date: May 25, 2022
• Recall Status: Terminated on March 04, 2026
• Recall Number: Z-1134-2022
• Recall Event ID: 90041
• Product Classification: Protector, ostomy - Product Code EXE
• Product: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
• Code Information: Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
• FEI Number: 3011987967
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7815 National Service Rd Ste 600; Greensboro NC 27409-9403
• For Additional Information Contact: 336-547-3730
• Manufacturer Reason for Recall: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
• FDA Determined Cause: Under Investigation by firm
• Action: The consignee recall notification was sent out via the United Pacel Service on 04/22/2022. The letter instructs the consignee to not use the product and complete the recall response form. The consignee should call the toll-free number to arrange a return.
• Quantity in Commerce: 600 market units
• Distribution: Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.