FDA Device recall Z-1278-2015
Puritan absorbent foam tipped applicator
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of Puritan absorbent foam tipped applicator by Puritan Medical Products, citing shaft breaks so that adequate patient specimen sample cannot be obtained.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1278-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-22 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Puritan Medical Products |
| Distribution | GA, ME, MS, NC |
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.
Identifiers
| code_info | Lot Number 3111, Expiration date: 2016/04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.