Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx,

FDA device recall Z-1260-06 · posted 2006-07-26 · Terminated

Recall details

Recalling firm

Radiometer America Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CHL

Quantity affected

2500 Units in U.S. & 76 Units in Canada

Distribution

Nationwide to user/customers in the U.S. and in Canada

Date initiated

2006-05-22

Date posted

2006-07-26

Date terminated

2012-04-17

Location

Westlake, OH