10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Recall Z-0006-2024 · Posted 2023-10-06
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeFMF
Date Initiated2023-08-08
Product Quantity124,773 boxes total
Reason for Recall
There is a potential for blood backfill leakage
and foreign material.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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