BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure to meet sterility assurance levels in medical devices poses a significant risk of infection, meeting the criteria for a Severe rating.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets, Catalog 367344. The recall is due to the products not meeting the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
The affected products were distributed in the United States (Nationwide), Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland, and Lithuania. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers should stop using the affected blood collection sets and contact Becton Dickinson & Company for further instructions or a replacement.
The recalled product
- Product
- BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
- Manufacturer
- Becton Dickinson & Company
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Company 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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