Z-0256-2023 Class II Ongoing
FDA device recall Z-0256-2023 was initiated by 3M Healthcare Business on October 6, 2022 and is designated Class II. 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. Addition… The recall status is ongoing. Affected quantity: 104,000 units.
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
- 104,000 units
Product Description
3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, 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)50707387497410, Lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, 33K888