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Terminated

D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.

FDA Recall Z-1319-06 · Posted 2006-08-02

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2005-06-17
Date Terminated2011-09-14
Product Quantity13 boxes/4 membranes per box

Reason for Recall

The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.

Firm Action

The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.

Root Cause

Other

Distribution Pattern

Nationwide, including TX, OK, MI, CO, NY, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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