Excelsior Heparin Lock Flush Syringes Recalled for Potency Failure
Excelsior Medical Corp is recalling specific lots of Heparin Lock Flush syringes because they failed potency testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Excelsior Medical Corp is recalling certain lots of Heparin Lock Flush, USP Syringes (5 mL Fill in 10 mL Syringe). These medical devices are used for flushing IV catheters and IV tubing.
The recall was initiated because the affected syringes failed the Anti-Factor IIa assay for potency during testing of retention samples for heparin potency. The source text does not specify the exact number of units affected or the specific distribution locations, though the product is intended for medical use.
Healthcare providers and consumers should stop using the affected lots immediately. The specific product codes, lot numbers, and expiration dates for the recalled items are 513604 (Lot 3123326, Exp 7/1/2016), E0500-55 (Lot 3123349, Exp 7/1/2016), and 513602 (Lot 3126577, Exp 8/1/2017).
The recalled product
- Product
- Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
- Manufacturer
- Excelsior Medical Corp
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 184,500
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)
- Product Code
- Lot number
Distribution
Distributed nationwide across the United States.
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