Recall Z-0119-2019 ยท FMF Syringe, Piston
Cypress Medical Products LLC
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
| Date | Sep 4, 2018 |
| Status | Terminated |
| Reason | Small hole at the end of the syringe is impeding suction of liquid. |
| Root cause | Equipment maintenance |
| Action | Cypress Medical Products LLC notified the distributor, McKesson Medical-Surgical, on 9/4/18. McKesson Medical-Surgical is responsible for communications to the distribution centers and end users. Any material on hand at end user facilities will be returned to the McKesson DC. Accounts requested to cease distribution and quarantine product for return. A response form included with letter to be completed and returned. |
| Quantity | 400 cases |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE Shinchang Medical Co., Ltd., Feb 25, 2000 |