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Terminated

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 Recall Z-0942-03 · Posted 2003-06-12

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeKNW
Date Initiated2003-06-02
Date Terminated2003-09-08
Product Quantity50 needles

Reason for Recall

The product was shipped prior to being sterilized.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962907SKINNY,FRANSEEN,WESCOTT NEEDLESBaxter Healthcare Corp · 1996-10-23

Official Source

View FDA Recall →

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

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