FDA Medical Device Recalls (openFDA)
Puritan Medical Products Co., LLC: 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 number
- Z-1278-2015
- Recalling firm
- Puritan Medical Products Co., LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-12-22
- Posted
- 2015-03-13
- Terminated
- 2015-03-18
- Reason
- Shaft breaks so that adequate patient specimen sample cannot be obtained.
- Root cause
- 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
- 9 cases of 500 applicators each
- Distribution
- Distributed in the states of MS, ME, GA, and NC.
- Lot, serial or model codes
- Lot Number 3111, Expiration date: 2016/04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KXG
- Firm FEI
- 1216735
- Firm city
- Guilford
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28