Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1260-06

Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx...

Radiometer America, Inc / initiated 2006-05-22 / Terminated

Radiometer America Inc began a recall of 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... on . The reason FDA records is "An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1260-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Radiometer America, Inc
Product
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
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall
An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.
FDA 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 in commerce
2500 Units in U.S. & 76 Units in Canada
Distribution
Nationwide to user/customers in the U.S. and in Canada
Product codes and lots
Model #842-326 & Model #842-327, no lot numbers supplied.