FDA Recall
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.
Recall: Z-1278-2015
·
Initiated December 22, 2014
Recall
- Recall Number
- Z-1278-2015
- Event Number
- 70270
- Firm
- Puritan Medical Products Co., LLC
- FEI Number
- 1216735
- Product Code
- KXG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 22, 2014
- Posted
- March 13, 2015
- Terminated
- March 18, 2015
- Address
- 31 School Street P.O. Box 149, Guilford, ME, 04443-0149
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
Shaft breaks so that adequate patient specimen sample cannot be obtained.
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.
Distribution
Distributed in the states of MS, ME, GA, and NC.
Quantity
9 cases of 500 applicators each