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.
This recall has been terminated (originally issued July 3, 2007).
- Company
- Radiometer America Inc
- Recall Initiated
- June 22, 2006
- Posted
- July 3, 2007
- Terminated
- May 8, 2012
- Recall Number
- Z-0975-2007
- Quantity
- 175 boxes
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The clinitubes are not able to be filled due to contamination with silicone during production.
Distribution
Nationwide and Canada.
Lot / Code Info
Lot R0043, exp. 01/2008; R0044, exp. 01/2008; and R0045, exp. 03/2008.
Root Cause
Other
Action Taken
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.
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