Recall Z-1278-2015— Puritan Medical Products Co., LLC

Class II · Terminated

Class II FDA medical device recall by Puritan Medical Products Co., LLC, initiated 2014-12-22, terminated 2015-03-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Shaft breaks so that adequate patient specimen sample cannot be obtained..

Recalling firm
Puritan Medical Products Co., LLC
Classification
Class II
Status
Terminated
Initiated
2014-12-22
Terminated
2015-03-18
Firm location
Guilford, ME, United States

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.