BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use
FDA device recall Z-2632-2014 · posted 2014-09-12 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Products were held at improper storage temperature
- 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.
- Root cause
- Storage
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 2 each
- Distribution
- Distributed in the states of LA, OK, and TX.
- Date initiated
- 2014-06-23
- Date posted
- 2014-09-12
- Date terminated
- 2021-01-29
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 (K041071) | Becton, Dickinson & CO | 2004-05-14 |