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U.S. Department of Health and Human Services

Class 1 Device Recall Sanxin Sterile Syringe For Single Use

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  Class 1 Device Recall Sanxin Sterile Syringe For Single Use see related information
Date Initiated by Firm August 08, 2023
Date Posted October 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0007-2024
Recall Event ID 92906
510(K)Number K050999  
Product Classification Syringe, piston - Product Code FMF
Product 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Code Information UDI-DI: 16945060500101; 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 2		 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 and Original Applicant = JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
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