Medical device recalls Moderate risk

Hospira Inc. recalls Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of dru…

Recall date
February 19, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1016-2017
FDA classification
Class II
Brand / firm
Hospira Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.

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

What was recalled

Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

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