10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA device recall Z-0006-2024 · posted 2023-10-06 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- There is a potential for blood backfill leakage and foreign material.
- Action taken
- 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. However, please monitor and be attentive of these potential issues prior to and immediately during use. Please sign and return the completed reply form (enclosed) for confirmation that you have received this notice. We apologize for any inconvenience this action may have caused and appreciate your cooperation.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 124,773 boxes total
- Distribution
- US Nationwide.
- Date initiated
- 2023-08-08
- Date posted
- 2023-10-06
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| YI XIN STERILE SYRINGE FOR SINGLE USE (K050999) | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005-09-02 |