BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
This recall has been terminated (originally issued September 12, 2014).
- Recall Initiated
- June 23, 2014
- Posted
- September 12, 2014
- Terminated
- January 29, 2021
- Recall Number
- Z-2629-2014
- Quantity
- 3 boxes
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Products were held at improper storage temperature
Distribution
Distributed in the states of LA, OK, and TX.
Lot / Code Info
Lot::3319877
Root Cause
Storage
Action Taken
Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate or BD Collection Tubes. If customers have the affected product, they will be instructed to contact FMC-RTG Customer Service to have the product replaced. On July 10, 2014 Fresenius issued a clarification letter to users to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as the products were exposure to higher temperatures than recommended. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.