Recall Z-2712-2024 ยท OHD Gynecological Laparoscopic Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBOTIC, REF DYNJ907156A
| Date | Aug 22, 2024 (initiated Mar 22, 2024) |
| Status | Open, Classified |
| Reason | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees. |
| Quantity | 964 units |
| Distribution | Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.