FDA Enforcement
Class II
Terminated
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Recall: Z-1134-2022
·
Reported June 1, 2022
Enforcement
- Recall Number
- Z-1134-2022
- Event ID
- 90041
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- ConvaTec, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 1, 2022
- Initiation Date
- April 22, 2022
- Classification Date
- May 25, 2022
- Termination Date
- March 4, 2026
- Address
- 7815 National Service Rd Ste 600, Greensboro, NC, 27409-9403, United States
Description
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
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.
Code Info
Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
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