Recall Z-0646-2025 ยท OJF Hysterectomy Kit
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYN
| Date | Dec 5, 2024 (initiated Oct 9, 2024) |
| Status | Open, Classified |
| Reason | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| Root cause | Under Investigation by firm |
| Action | Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-0 |
| Quantity | 3452 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.