Medical device recalls Moderate risk

Puritan Medical Products Co., LLC recalls Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used…

Recall date
December 22, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1278-2015
FDA classification
Class II
Brand / firm
Puritan Medical Products Co., LLC
Sold / distributed
Distributed in the states of MS, ME, GA, and NC.

Why it was recalled

Shaft breaks so that adequate patient specimen sample cannot be obtained.

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

What was recalled

Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.

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