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
FDA Recall Z-2189-2015 · Posted 2015-07-21
Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2015-06-18
Date Terminated2016-06-23
Product Quantity10290 units
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.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.