ConvaTec, Inc Recall 90041
Description: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
ConvaTec, Inc Recall 90041 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1134-2022 |
| Event ID | 90041 |
| Event Description | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. |
| Product Type | Devices |
| 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. |
| Quantity | 600 market units |
| Recall Reason | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. |
| Device Classification | 20220601 |
| Device Code Info | Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189 |
| Center Classification Date | 20220525 |
| Recall Initiation Date | 20220422 |
| Recalling Firm | ConvaTec, Inc |
| Initial Notification | Letter |
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