Fresenius Recalls BD Vacutainer Trace Element Tubes Due to Storage Issues
Fresenius Medical Care is recalling specific BD Vacutainer Trace Element 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 quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling BD Vacutainer Trace Element Tubes (Royal Blue Top Tube 6.0ml), Part Number 363083 and FMC 87-8380-1. These single-use tubes are used to collect, separate, transport, or process blood specimens for laboratory determinations for in vitro diagnostic use, specifically for trace elements, aluminum, and zinc determination.
The recall was initiated because the products were held at improper storage temperature. The affected units are identified by Lot 4007096. The quantity involved is 2 each.
The products were distributed in the states of Louisiana, Oklahoma, and Texas. Consumers and healthcare facilities should stop using these specific tubes and contact the recalling firm for further instructions.
The recalled product
- Product
- BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- 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: 4007096
Distribution
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.
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