Becton Dickinson Recalls BD Vacutainer Plus SST Tubes Due to Stopper Defect
Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tubes.
What this means for you
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 the hazard involves a structural defect in a medical device that could compromise sample integrity or safety, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Company is recalling approximately 9.5 million units of BD Vacutainer Plus SST Tubes with HEMOGARD closure, Catalog No. 367983. The recall is being conducted because the tubes may exhibit stopper creepout or pullout, where the stopper dissociates from the tube.
The affected products were distributed nationwide in the United States and in several international locations, including Argentina, Belize, Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, and Taiwan. The specific lot numbers and expiration dates for the recalled items are 7315828 (expiring 5/31/2018) and 7125692 (expiring 4/30/2018).
Healthcare facilities and consumers should check their inventory for these specific catalog numbers and lot codes. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 9,568,900
Distribution
Part of a larger recall action
This product is one of 2 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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