BD Vacutainer Plus SST Tubes Recalled for Stopper Defect
Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tube.
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 lead to sample loss or contamination, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986. The recall involves 9,568,900 units of the product.
The recall was initiated because the tubes may exhibit stopper creepout or pullout, where the stopper dissociates from the tube. This defect could potentially compromise the integrity of the sample collection process.
The affected products were distributed in the US Nationwide, Argentina, Belize, Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, and Taiwan. The specific lot number is 7146901, and the expiration date is 5/31/2018. Users should check their inventory for this specific catalog number and lot number and stop using the affected products.
The recalled product
- Product
- BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 9,568,900
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)
- UDI DI (01)50382903679862 Lot/Serial# 7146901 Exp Date 5/31/2018
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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