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Terminated

Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601

FDA Recall Z-2188-2015 · Posted 2015-07-21

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2015-06-18
Date Terminated2016-06-23
Product Quantity6390 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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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