Recall Z-0975-2007 ยท GIO Tube, Collection, Capillary Blood
Radiometer America Inc
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.
| Date | Jul 3, 2007 (initiated Jun 22, 2006) |
| Status | Terminated |
| Reason | The clinitubes are not able to be filled due to contamination with silicone during production. |
| Root 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 | 175 boxes |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.