Product Description
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Reason for Recall
There is a potential for blood backfill leakage
and foreign material.
Action Details
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.
Distribution Pattern
US Nationwide.
Code Information / Serial Numbers
UDI-DI: 16945060501122;
All Lots
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.