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U.S. Department of Health and Human Services

Class 2 Device Recall SafeClinitubes, REF 942892.

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  Class 2 Device Recall SafeClinitubes, REF 942892. see related information
Date Initiated by Firm June 22, 2006
Date Posted July 03, 2007
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0975-2007
Recall Event ID 37526
Product Classification capillary tubes - Product Code GIO
Product SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.
Code Information Lot R0043, exp. 01/2008; R0044, exp. 01/2008; and R0045, exp. 03/2008.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
440-871-8900
Manufacturer Reason
for Recall		 The clinitubes are not able to be filled due to contamination with silicone during production.
FDA Determined
Cause 2		 Other
Action The firm notified their customers of this recall with a letter dated 6/22/2006. The letter informs the customers of the problem with the affected lots of SafeCLINITUBES and asks that the customers discard any remaining boxes of affected product on-site. The recall letter is accompanied by a FAX FORM (response form) which the customer is asked to complete in order to request replacement product to be sent to their individual locations.
Quantity in Commerce 175 boxes
Distribution Nationwide and Canada.
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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