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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan absorbent foam tipped applicator

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  Class 2 Device Recall Puritan absorbent foam tipped applicator see related information
Date Initiated by Firm December 22, 2014
Date Posted March 13, 2015
Recall Status1 Terminated 3 on March 18, 2015
Recall Number Z-1278-2015
Recall Event ID 70270
Product Classification Applicator, absorbent tipped, sterile - Product Code KXG
Product 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.
Code Information Lot Number 3111, Expiration date: 2016/04
Recalling Firm/
Puritan Medical Products Co., LLC
31 School Street
P.O. Box 149
Guilford ME 04443-0149
For Additional Information Contact
Manufacturer Reason
for Recall
Shaft breaks so that adequate patient specimen sample cannot be obtained.
FDA Determined
Cause 2
Process control
Action Consignees were initially notified of the recall via phone on 12/23/2014 and 12/29/2014. They were informed that the product may have been over exposed to gamma radiation, resulting in brittle sticks. They were instructed to not use the product for patient sampling and to return any product remaining in inventory to Puritan.
Quantity in Commerce 9 cases of 500 applicators each
Distribution Distributed in the states of MS, ME, GA, and NC.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.