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U.S. Department of Health and Human Services

Class 2 Device Recall V. Mueller

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  Class 2 Device Recall V. Mueller see related information
Date Initiated by Firm August 28, 2009
Date Posted November 09, 2009
Recall Status1 Terminated 3 on May 12, 2010
Recall Number Z-0141-2010
Recall Event ID 53137
Product Classification Vertebral Biopsy set component - Product Code FCG
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
Code Information catalog #OS5000-005, lot number K08
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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