Recall Z-0277-2027 ยท PUI Drape, Surgical, Exempt
Medline Industries, LP
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.
| Date | Oct 22, 2026 (initiated Sep 9, 2026) |
| Status | Open, Classified |
| Reason | Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. |
| Root cause | Under Investigation by firm |
| Action | MEDLINE issued a MEDICAL DEVICE CORRECTION notice to its consignees on 9/9/2023 via US mail and email. The notice explained the issue and circumstances under which it can occur, hazard involved, and requested the user follow specific patient skin preparation, product application considerations, and removal recommendations. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 545 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.