—#103725

Product

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 product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K093972
Affected lot / code info: Lot # 1018904 Catalog # 363706

Why it was recalled

BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distributed only to Florida.

Timeline

Recall initiated: 2011-02-11
Posted by FDA: 2011-11-08
Terminated: 2011-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.