3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Recall
- Recall Number
- Z-0007-2024
- Event Number
- 92906
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Product Code
- FMF
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 8, 2023
- Posted
- October 6, 2023
- Address
- 920 Winter St, Bld 920, Waltham, MA, 02451-1521
Description
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
There is a potential for blood backfill leakage and foreign material.
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.
US Nationwide.
124,773 boxes total