Z-1278-2015Class II

Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped...

Name: Z-1278-2015 Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped...
Creator: Puritan Medical Products Co., LLC
Published: 2014-12-22
License: https://open.fda.gov/license/

Puritan Medical Products Company, LLC / initiated 2014-12-22 / Terminated / root cause: manufacturing process

FDA source

Puritan Medical Products Co., LLC began a recall of Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain... on 2014-12-22. FDA classified it as Class II and gives the reason as "Shaft breaks so that adequate patient specimen sample cannot be obtained". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1278-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-22
Posted: 2015-03-13
Terminated: 2015-03-18
Recalling firm: Puritan Medical Products Company, 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.
Product code: KXG Applicator, Absorbent Tipped, Sterile
Reason for recall: Shaft breaks so that adequate patient specimen sample cannot be obtained.
Root cause tag: manufacturing process
FDA 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 in commerce: 9 cases of 500 applicators each
Distribution: Distributed in the states of MS, ME, GA, and NC.
Product codes and lots: Lot Number 3111, Expiration date: 2016/04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1278-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1278-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-13

Product code KXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)