BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients.
FDA Recall Z-0176-2012 · Posted 2011-11-08
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2011-02-11
Date Terminated2011-11-10
Product Quantity10,800 units
Reason for Recall
BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.
Firm Action
A Becton Dickinson Sales Consultant conducted a "on-site" visit to the single Customer account, Florida Hospital, on February 11, 2011.
All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed.
If you have any questions or request additional information please do not hesitate to call (201) 847-5636.
Root Cause
Device Design
Distribution Pattern
Distributed only to Florida.
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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