3M Healthcare Business Recall 90989
Description: 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
3M Healthcare Business Recall 90989 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0264-2023 |
| Event ID | 90989 |
| Event Description | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 17,200 units |
| Recall 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. |
| Device Classification | 20221130 |
| Device Code Info | UDI/DI (01)30707387018741, Lot numbers: 33HJ3C, 33HTFH, 33J9CT, 33JED6, 33JJHN, 33K968, 33KTRH |
| Center Classification Date | 20221118 |
| Recall Initiation Date | 20221006 |
| Recalling Firm | 3M Healthcare Business |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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