Recall Z-1918-2024 ยท OJH Orthopedic Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray
| Date | May 29, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Trumpet Needle Guide ring can detach when excessive pressure is applied. |
| Root cause | Process control |
| Action | Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers. |
| Quantity | 12994 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.