—#152718

Product

HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K980196
Affected lot / code info: lots: 11158857

Why it was recalled

The recalling firm received a complaint from one of their customers of a 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)

Equipment maintenance

Action the firm took

Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

Timeline

Recall initiated: 2017-01-18
Posted by FDA: 2017-02-13
Terminated: 2017-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152718. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.