T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
This recall has been terminated (originally issued July 21, 2015).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- June 18, 2015
- Posted
- July 21, 2015
- Terminated
- June 23, 2016
- Recall Number
- Z-2189-2015
- Quantity
- 10290 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Distribution
US
Lot / Code Info
Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173
Root Cause
Packaging process control
Action Taken
The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.