BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
FDA Recall Z-2633-2014 · Posted 2014-09-12
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2014-06-23
Date Terminated2021-01-29
Product Quantity2 each
Reason for Recall
Products were held at improper storage temperature
Firm 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 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
Distribution Pattern
Distributed in the states of LA, OK, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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