Recall Z-2358-2019 ยท EYN Tray, Irrigation, Sterile
Medline Industries Inc
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
| Date | Aug 9, 2019 |
| Status | Open, Classified |
| Reason | Samples in the identified lot were found to have incomplete or open packaging seals. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified via first class mail on August 9, 2019. The letter requested the following: 1. Immediately check your stock for item number DYNC2303 and the affected lot number, 19CAB954. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form as indicated. When we receive your completed destruction form your account will be is |
| Quantity | 11962 trays |
| 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.