Recall Z-0258-2023 ยท PUI Drape, Surgical, Exempt
3M Healthcare Business
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
| Date | Nov 18, 2022 (initiated Oct 6, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | The firm began disseminating an URGENT Product Recall notice their consignees by email or letter beginning 10/06/2022. The notice explained the issue and requested the following: Distributors: "Actions Requested: 1. Immediately discontinue distribution of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. 3. Complete the Distributor Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you |
| Quantity | 43,200 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.