PICC/CVC Secure Dressing Change kit recalled over labeling errors

Recall date

February 3, 2016

Source

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

Official notice title

Medical Action Industries Inc recalls PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden…

Recall number

Z-1036-2016

FDA classification

Class II

Brand / firm

Medical Action Industries Inc

Sold / distributed

Nationwide distribution to MO, NE and TX .

Why it was recalled

Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

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

What was recalled

PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings