Recall Z-2632-2014 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.
| Date | Sep 12, 2014 (initiated Jun 23, 2014) |
| Status | Terminated |
| Reason | Products were held at improper storage temperature |
| Root cause | Storage |
| Action | 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 |
| Quantity | 2 each |
| Distribution | Distributed in the states of LA, OK, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 Becton, Dickinson & CO, May 14, 2004 |