Z-0141-2010

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

Name: Z-0141-2010 Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold...
Creator: Cardinal Health
Published: 2009-08-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-08-28 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of 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... on 2009-08-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0141-2010
Status: Terminated
Initiated: 2009-08-28
Posted: 2009-11-09
Terminated: 2010-05-12
Recalling firm: Medtronic, Inc.
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
Product code: FCG Biopsy Needle
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 19 units
Distribution: Nationwide distribution.
Product codes and lots: catalog #OS5000-005, lot number K08

Product code FCG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)