FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Brand
Radiometer America Inc
UPC
Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.

Units Affected

13 boxes/4 membranes per box