Medical device recalls Moderate risk

Medical Components, Inc dba MedComp recalls Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot…

Recall date
May 5, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1924-2016
FDA classification
Class II
Brand / firm
Medical Components, Inc dba MedComp
Sold / distributed
US Distributed to: FL, TX, NC

Why it was recalled

This recall has been initiated due to the product labeled with the incorrect expiration date.

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

What was recalled

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

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