Reported Jun 22, 2016 · Terminated
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters…
Excelsior Medical Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Excelsior Medical Corp · 1933 Heck Ave · Neptune, NJ · 07753-4428
Is this the product you have?
- Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
- Lot codes and dates
- Product Code, Lot number, Expiration date.
51360431233267/1/2016E0500-5531233497/1/201651360231265778/1/2017
- Product Code, Lot number, Expiration date.
- Amount recalled
- 184,500
Where it was sold
- Nationwide
Why it was recalled
Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
This product could cause temporary or reversible health problems — stop using it.
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