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Recall Observatory FDA recall evidence

Device product

BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

Z-2630-2014

June 23, 2014

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 68585
Status
Terminated
Classification
Class II
Quantity
26 boxes
Official record key
device-enforcement:Z-2630-2014

Official wording

Reason: Products were held at improper storage temperature

Code information: Lot: 3343067

Distribution pattern: Distributed in the states of LA, OK, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products were held at improper storage temperature