Medical device recalls Moderate risk

Hospira Inc. recalls *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site,…

Recall date
September 9, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2060-2016
FDA classification
Class II
Brand / firm
Hospira Inc.
Sold / distributed
US (Nationwide) Distribution

Why it was recalled

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

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

What was recalled

*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

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