10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0… recallZ-0005-2024 · Fresenius Medical Care Holdings, Inc. · initiated Aug 8, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for blood backfill leakage and foreign material.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0005-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2023
- Posted by the FDA
- Oct 6, 2023
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 124,773 boxes total
- Product code
- FMF
- FDA submissions
- K050999
- Distribution
- US Nationwide.
Product description
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Code information (models, lots, serial numbers)
UDI-DI: 16945060501122; All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- YI XIN Sterile Syringe For Single Use Three-piece 10mLJiang Xi Sanxin Medtec Co., Ltd. · Syringe, Piston1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K050999 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- YI XIN Sterile Syringe For Single Use Three-piece 3mLJiang Xi Sanxin Medtec Co., Ltd. · Syringe, Piston1 recall0 reports
- YI XIN Sterile Syringe For Single Use Three-piece 10mLJiang Xi Sanxin Medtec Co., Ltd. · Syringe, Piston1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92906).
- Z-0006-2024 · Open, Classified10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
- Z-0007-2024 · Open, Classified3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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