BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part ***
FDA device recall Z-0643-2010 · posted 2010-01-15 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
- Action taken
- The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KZI
- Quantity affected
- 144 boxes
- Distribution
- Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.
- Date initiated
- 2009-02-19
- Date posted
- 2010-01-15
- Date terminated
- 2010-02-12
- Location
- Sparks, MD
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