Z-0005-2024Class I

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Name: Z-0005-2024 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2023-08-08
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2023-08-08 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case on 2023-08-08. FDA classified it as Class I and gives the reason as "There is a potential for blood backfill leakage and foreign material". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0005-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2023-10-06
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Product code: FMF Syringe, Piston
Reason for recall: There is a potential for blood backfill leakage and foreign material.
Root cause tag: design
FDA root 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.
Product codes and lots: UDI-DI: 16945060501122; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0006-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0007-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code FMF

K050999Class IIYi Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group / cleared 2005-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)