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Terminated

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.

FDA Recall Z-1278-2015 · Posted 2015-03-13

Recalling FirmPuritan Medical Products Co., LLC
Recall StatusTerminated
Product CodeKXG
Date Initiated2014-12-22
Date Terminated2015-03-18
Product Quantity9 cases of 500 applicators each

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Distributed in the states of MS, ME, GA, and NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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