Class 2 Device Recall SafeClinitubes, REF 942892.

• Date Initiated by Firm: June 22, 2006
• Date Posted: July 03, 2007
• Recall Status: Terminated 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: 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.