Excelsior Medical Corp recalls Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters…

Recall date

April 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1989-2016

FDA classification

Class II

Brand / firm

Excelsior Medical Corp

Sold / distributed

US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.