The Recall Desk
ModerateFDA (Devices)·Z-2630-2014·Announced 2014-09-24

Fresenius Recalls BD Vacutainer EDTA Tubes Due to Improper Storage

Fresenius Medical Care is recalling 26 boxes of BD Vacutainer EDTA tubes held at improper storage temperatures. The affected lots were distributed in Louisiana, Oklahoma, and Texas.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a storage temperature issue, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 26 boxes of BD Vacutainer EDTA Tubes (Lavender Top Tube 2.0ml), Part Number BD 367841 and FMC 87-7841-7. These single-use tubes are used to collect, separate, transport, or process blood specimens for laboratory determinations for in vitro diagnostic use.

The recall was initiated because the products were held at improper storage temperature. The affected lot number is 3343067. The products were distributed in the states of Louisiana, Oklahoma, and Texas.

Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for instructions on return or disposal.

The recalled product

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.
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 3343067

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 6 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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