Device 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.
Z-1278-2015
Product summary
- Event
- Event 70270
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 cases of 500 applicators each
- Official record key
device-enforcement:Z-1278-2015
Official wording
Reason: Shaft breaks so that adequate patient specimen sample cannot be obtained.
Code information: Lot Number 3111, Expiration date: 2016/04
Distribution pattern: Distributed in the states of MS, ME, GA, and NC.
Derived failure modes
-
Unknown
Shaft breaks so that adequate patient specimen sample cannot be obtained.