Z-1196-2007

ABL80 FLEX Analyzer, Model #393-839

Name: Z-1196-2007 ABL80 FLEX Analyzer, Model #393-839
Creator: Sendx Medical Inc
Published: 2007-03-27
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2007-03-27 / Terminated

FDA source

Sendx Medical Inc began a recall of ABL80 FLEX Analyzer, Model #393-839 on 2007-03-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1196-2007
Status: Terminated
Initiated: 2007-03-27
Posted: 2007-08-25
Terminated: 2011-10-13
Recalling firm: Sendx Medical, Inc.
Product: ABL80 FLEX Analyzer, Model #393-839
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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 root cause: Other
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.
Product codes and lots: All analyzers produced between 10/26/06 to 3/15/07 are being recalled (serial code/lot code range of 300101 to 300517)

Product code CHL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)