ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
FDA Recall Z-1320-06 · Posted 2006-08-03
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2005-06-09
Date Terminated2012-02-24
Product Quantity155 bags
Reason for Recall
The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results.
Firm Action
The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.
Root Cause
Other
Distribution Pattern
Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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