Recall Z-0005-2024 ยท FMF Syringe, Piston
Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
| Date | Oct 6, 2023 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for blood backfill leakage and foreign material. |
| Root cause | Device Design |
| Action | An URGENT PRODUCT RECALL notification letter dated 8/8/23 was sent to customers. For return of unused product: Please check your stock. If you have any of the product(s) listed above, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o Reference to FA-2023-17-C RECALL o Specify if urgent replacement of product is needed when calling. NOTE: If you have no other product other than Sanxin, you may use in order to continue treatments until you receive replacement product. Ho |
| Quantity | 124,773 boxes total |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050999 | YI XIN STERILE SYRINGE FOR SINGLE USE Jiangxi Sanxin (Eversincere) Medical Devices Group, Sep 2, 2005 |