—#138121

Product

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 product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K980196
Affected lot / code info: Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173

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 #138121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.