Reported Jan 6, 2016 · Terminated
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried),…
Becton Dickinson & Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815
Is this the product you have?
- BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0
- mL (Lavender) BD Hemogard AdditiveK2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening
- Lot codes and dates
- Catalog Reference #367844; Lot number 5154624 Catalog Reference #367862; Lot numbers 5089771 and 5187753 Catalog Reference #368021; Lot number 5089820
- Amount recalled
- 29,815,600 units in total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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