The Recall Desk
ModerateFDA (Devices)·Z-2634-2014·Announced 2014-09-24

Fresenius Recalls BD Vacutainer PST Tubes Due to Improper Storage Temperature

Fresenius Medical Care is recalling BD Vacutainer PST Tubes because they were held at improper storage temperatures. The affected units 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. The hazard involves improper storage temperature, which is a low-risk contamination or handling issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling BD Vacutainer PST Tubes (Gold Top PST Tube 3ml), Part Number BD 367960, FMC Part Number 87-4544-4. These single-use tubes are used to collect, separate, transport, or process blood specimens for laboratory determinations for in vitro diagnostic use. The recall involves 13 units from Lot B011403.

The recall was initiated because the products were held at improper storage temperatures. The affected units 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 further instructions.

The recalled product

Product
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be
Affected units
13

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: B011403

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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