Z-0251-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 807,720 units
Product Description
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
Reason for Recall
During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI (01)50707387023756, Lot numbers: 33HR7D, 33HR94, 33HRET, 33HRWK, 33HT5X, 33HTDY, 33J4XP, 33J583, 33J5FA, 33JEF8, 33JEM5, 33JEYA, 33JWHK, 33JWLX, 33JWRH, 33JX5M, 33JXFA, 33JXPK, 33JY6E, 33JYEM, 33JYM4, 33JYXH, 33KD6N, 33KKET, 33KKMT, 33KL65, 33KLAR, 33L34N, 33L3JN, 33L3LT, 33L44T, 33LLC5