Class 1 Device Recall Sanxin Sterile Syringe For Single Use

• Date Initiated by Firm: August 08, 2023
• Date Posted: October 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0006-2024
• Recall Event ID: 92906
• 510(K)Number: K050999
• Product Classification: Syringe, piston - Product Code FMF
• Product: 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
• Code Information: UDI-DI: 16945060500125; All Lots
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St Bld 920; Waltham MA 02451-1521
• For Additional Information Contact: Fresenius Medical Care Customer Service; 800-323-5188
• Manufacturer Reason for Recall: There is a potential for blood backfill leakage and foreign material.
• FDA Determined 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. 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.
• Quantity in Commerce: 124,773 boxes total
• Distribution: US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMF