—#84750

Product

Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: catalog #OS5000-005, lot number K08

Why it was recalled

The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Cardinal Health sent Urgent Product Recall letters dated 8/28/09 to all customers who received the product during the recalled period on the same day via UPS Next Day Air. The accounts were informed of the problem with the cannula, and were instructed to functionally test the cannula by passing the toothed cutter within it to ensure the cutter advances freely into the cannula. If any restriction is noticed, the product should be segregated and returned to Cardinal Health. The accounts were requested to complete and return by fax the enclosed acknowledgement form, indicating the number of affected cannulas being returned. Any questions were directed to V. Mueller Customer Service at 800-323-9088.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2009-08-28
Posted by FDA: 2009-11-09
Terminated: 2010-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84750. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.