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U.S. Department of Health and Human Services

Class 2 Device Recall ABL80 FLEX Analyzer

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 Class 2 Recall
ABL80 FLEX Analyzer
see related information
Date Posted August 25, 2007
Recall Status1 Open
Recall Number Z-1196-2007
Recall Event ID 38172
Premarket Notification
510(K) Number
K051804 
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product ABL80 FLEX Analyzer, Model #393-839
Code Information All analyzers produced between 10/26/06 to 3/15/07 are being recalled (serial code/lot code range of 300101 to 300517)
Recalling Firm/
Manufacturer
Sendx Medical Inc
1945 Palomar Oaks Way
Carlsbad, California 92009-1307
For Additional Information Contact Doreen E. Milford
760-930-6300
Manufacturer Reason
for Recall
There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.
FDA Determined
Cause 2
DESIGN: Device Design
Action The recall was initiated 3/27/2007. All distributors were notified via the Radiometer FAN (field action notice) system which provides a communication mechanism for these types of actions. The notice advises that there have been a few reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer which occurs when excessive pressure builds within the waste line. To prevent any spraying of fluids from the waste drain a check valve has been added to the waste tubing, between the waste drain and the waste pump which allows fluids to flow in one direction thus making it impossible to spray fluids out the waste drain. The letter further advises that all analyzers shipped from SenDx on or after March 16, 2007 will include this check valve. All analyzers already in the field must be updated to include this check valve. Distributors are to distribute a copy of the Customer Advisory Letter associated with this case to all their customers and update all ABL80 analyzers to include the waste drain check valve as per the instructions that accompany the check valve. The Advisory Letter informs the customer of the problem and the new waste drain check valve and provides precautionary instructions such as appropriate hand, eye, face and clothing shields. In addition, it advises that the analyzer should never be used if there is any indication of a waste drain occlusion or blockage. The most typical indication of an occlusion or blockage is fluid overflowing out of the waste drain.
Quantity in Commerce 334 units worldwide
Distribution Class II Recall - Worldwide Distribution --- USA including state of Ohio, and countries of Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, The Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, New Zealand, Canada, and Denmark.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = SENDX MEDICAL, INC.
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