Recall Z-1321-06 ยท GIO Tube, Collection, Capillary Blood
Radiometer America Inc
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
| Date | Aug 3, 2006 (initiated Mar 22, 2006) |
| Status | Terminated |
| Reason | Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport. |
| Root cause | Other |
| Action | The firm notified their customers of this recall action with a letter dated 3/22/2006. The letter was accompanied by a single bag of new end caps. The letter informs the customers of the ''leakage'' problem and asks that the customer examine their inventories and discard any of the referenced end caps found on-hand at any of their various locations. The letter also includes a response form to be faxed back to Radiometer indicating the amount of replacement capillary end caps required by the customer in addition to the one bag received. The recalling firm also notified the customers that the |
| Quantity | Red Caps: 178 kits Each kit contains 1 to 5 bags of caps |
| Distribution | Nationwide, Canada and Istanbul. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.