Recall Z-1260-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671
| Date | Jul 26, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution. |
| Root cause | Other |
| Action | The recalling firm issued a letter to their customers dated 5/22/2006. The letter informs the customer(s) of the tubing defect and provides the customer with one (1) tubing to deal with any immediate needs which they may have. Should the customer require additional waste pump tubing replacements, the letter is accompanied by a FAX FORM which can be used to request any amount of additional replacement tubing required. The letter also shows tthe address to which the replacement tubing is to be delivered, and provides a Purchase Order request to be used, if required. |
| Quantity | 2500 Units in U.S. & 76 Units in Canada |
| Distribution | Nationwide to user/customers in the U.S. and in Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.