Recalls / —
—#138118
Product
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 product code
- KNW — Instrument, Biopsy
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707
Why it was recalled
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- US
Timeline
- Recall initiated
- 2015-06-18
- Posted by FDA
- 2015-07-21
- Terminated
- 2016-06-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.