Recalls / —

—#202861

Product

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

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K050999

Affected lot / code info

UDI-DI: 16945060501122; All Lots

Why it was recalled

There is a potential for blood backfill leakage and foreign material.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

US Nationwide.

Timeline

Recall initiated

2023-08-08

Posted by FDA

2023-10-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.