—#27660

Product

Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K962907
Affected lot / code info: Catalog number CHI1815, lot D03AB0594

Why it was recalled

The product was shipped prior to being sterilized.

Root cause (FDA determination)

Other

Action the firm took

Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, McGaw Park, Illinois 60085

Distribution

Distribution pattern: Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.

Timeline

Recall initiated: 2003-06-02
Posted by FDA: 2003-06-12
Terminated: 2003-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27660. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.