Z-1278-2015 Class II Terminated
FDA device recall Z-1278-2015 was initiated by Puritan Medical Products Co., LLC on December 22, 2014 and is designated Class II. Reason for recall: Shaft breaks so that adequate patient specimen sample cannot be obtained. The recall status is terminated (terminated March 18, 2015). Affected quantity: 9 cases of 500 applicators each.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2015
- Initiation Date
- December 22, 2014
- Termination Date
- March 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 cases of 500 applicators each
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.
Distribution Pattern
Distributed in the states of MS, ME, GA, and NC.
Code Information
Lot Number 3111, Expiration date: 2016/04