Recall Z-0975-2007
Radiometer America Inc · initiated June 22, 2006
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.
Codes / lots: Lot R0043, exp. 01/2008; R0044, exp. 01/2008; and R0045, exp. 03/2008.
Reason for recall
The clinitubes are not able to be filled due to contamination with silicone during production.
FDA-determined 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.
Details
- Recall number
- Z-0975-2007
- Initiated
- June 22, 2006
- Posted by FDA
- July 3, 2007
- Terminated
- May 8, 2012
- Product code
- GIO – Tube, Collection, Capillary Blood
- Quantity
- 175 boxes
- Distribution
- Nationwide and Canada.
- Recalling firm
- Radiometer America Inc, Westlake, OH