BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing
FDA device recall Z-0176-2012 · posted 2011-11-08 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 10,800 units
- Distribution
- Distributed only to Florida.
- Date initiated
- 2011-02-11
- Date posted
- 2011-11-08
- Date terminated
- 2011-11-10
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 (K093972) | Becton, Dickinson & CO | 2010-01-21 |