FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material
Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, indicating a potential for serious adverse health consequences. The recall involves potential blood backfill leakage and foreign material in medical devices used for patient injections. No illnesses or injuries have been reported to date.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 10mL Luer lock syringes without needles (Part Number 15-R010-0) distributed nationwide. The recall affects 124,773 boxes total.
The FDA identified a potential for blood backfill leakage and foreign material in the devices.
Healthcare facilities that may have received these syringes should stop using them immediately. Facilities can verify whether they received affected product by checking the UDI-DI (16945060501122) on packaging.
The recalled product
- Product
- 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 124,773
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 16945060501122
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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