Device product
3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
Z-0260-2023
Product summary
- Event
- Event 90989
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,160 units
- Official record key
device-enforcement:Z-0260-2023
Official wording
Reason: 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.
Code information: UDI/DI (01)30707387018758, Lot numbers: 33HT6E, 33HWFM, 33HWMF, 33HX3K, 33K9TF, 33KA3T, 33KA95
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.