Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as

FDA device recall Z-0141-2010 · posted 2009-11-09 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FCG

Quantity affected

19 units

Distribution

Nationwide distribution.

Date initiated

2009-08-28

Date posted

2009-11-09

Date terminated

2010-05-12

Location

Park, IL