The Recall Desk
ModerateFDA (Devices)·Z-2633-2014·Announced 2014-09-24

Fresenius Medical Care Recalls BD Vacutainer Citrate Tubes Due to Storage Issues

Fresenius Medical Care is recalling BD Vacutainer Citrate Tubes because they were held at improper storage temperatures. The affected tubes 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 hospitalizations, injuries, or illnesses. The hazard is a storage temperature deviation, which is a quality control issue without reported adverse health consequences, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling BD Vacutainer Citrate Tubes (Light Blue Top Tube 2.7ml), part number BD 363083 (FMC 87-3083-8). These single-use tubes are used to collect, separate, transport, or process blood specimens for laboratory determinations for in vitro diagnostic use, specifically for coagulation studies.

The recall was initiated because the products were held at improper storage temperatures. The affected units, identified by Lot 4007362, were distributed in the states of Louisiana, Oklahoma, and Texas. The quantity involved in this recall is 2 each.

Consumers and healthcare facilities should stop using the affected BD Vacutainer Citrate Tubes and contact the recalling firm for further instructions or replacement.

The recalled product

Product
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.
Affected units
2

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: 4007362

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.

See all →