BD Vacutainer Push Button Blood Collection Set Recall for Barrel Separation
Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.
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 involves a medical device with a mechanical defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling 1,788,150 units of the BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing (Catalog # 367342). The product is intended for venipuncture to obtain blood specimens from patients.
The recall was initiated after BD received multiple reports that units from specific lots exhibit separation of the front and rear barrels upon activation of the safety feature, which retracts the needle. The affected lots are identified by the following codes: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634, and 6006650.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Canada, Belgium, and Brazil. Users should check their inventory for the affected lot codes and stop using the product if it matches the recalled lots.
The recalled product
- Product
- BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 1,788,150
Distribution
Distributed nationwide across the United States.
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