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BD Microtainer MAP Microtube for Automated Process with… recallZ-0176-2012 · Becton Dickinson & Company · initiated Feb 11, 2011

Terminated All recalls posted in November 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0176-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 11, 2011
Posted by the FDA
Nov 8, 2011
Recalling firm
Becton Dickinson & Company
Quantity
10,800 units
Product code
JKA
FDA submissions
K093972
Distribution
Distributed only to Florida.

Product description

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.

Code information (models, lots, serial numbers)

Lot # 1018904 Catalog # 363706

Other devices under the same FDA submission

1 device cleared under K093972 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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