Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent fo...
FDA Recall #Z-1278-2015 — Class II — December 22, 2014
Product Description
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.
Reason for Recall
Shaft breaks so that adequate patient specimen sample cannot be obtained.
Recalling Firm
Puritan Medical Products Co., LLC — Guilford, ME
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9 cases of 500 applicators each
Distribution
Distributed in the states of MS, ME, GA, and NC.
Code Information
Lot Number 3111, Expiration date: 2016/04
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated