Greiner Bio-One Recalls VACUETTE Safety Blood Collection Sets
Greiner Bio-One is recalling VACUETTE Safety Blood Collection Sets because a crack in the luer connector may cause small droplets of blood to leak during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used for blood collection where a defect (cracking/leaking) poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling 192,000 pieces (192 cases) of VACUETTE Safety Blood Collection Set + Luer Adapter, Item number 450096. The affected product is identified by Lot No. 12H27. These devices are used in routine venipuncture procedures.
The recall was initiated because the luer connector piece on the blood collection set may have a crack, which can result in leaking (small droplets) during use. The agency has classified this as a Class II recall.
The product was distributed nationwide in the states of Florida, Illinois, Kentucky, New York, North Carolina, Pennsylvania, Ohio, Texas, and Virginia. Users should stop using the affected blood collection sets and contact the manufacturer for further instructions.
The recalled product
- Product
- VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
- Manufacturer
- Greiner Bio-One North America, Inc.
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 No. 12H27
Distribution
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