Recall Z-3071-2024 ยท OJH Orthopedic Tray
MEDLINE INDUSTRIES, LP - Northfield
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
| Date | Sep 6, 2024 (initiated Jun 18, 2024) |
| Status | Open, Classified |
| Reason | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection. |
| Root cause | Process change control |
| Action | Medline Industries issued a Recall notice to its consignees on 06/18/2024 via email. The notice explained the issue, potential risk, and directed the product to be stickered to instruct the used to remove the recalled component from the kit and replace from sterile supply. Distributors or those who have transferred the product were directed to notify those to whom the product was distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 105 units |
| Distribution | US: TX, IL, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.