BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage
Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.
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: FDA Class II recall of a medical device with potential for serious patient harm including treatment interruption, biohazard exposure, and under-dosing. No injuries have been reported. Per the rubric, this qualifies as High (Score 3) for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD Connecta 3-Way Stopcocks (Catalog No. 394900, OUS) due to a potential manufacturing defect that may allow leakage at the housing component of the stopcock.
The affected units (54010 total) were distributed worldwide, including to hospitals and healthcare facilities across the United States and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The affected lot number is 1214380 with an expiration date of July 31, 2024.
A leak in the stopcock may result in treatment delay or interruption, exposure of patients to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress into the infusion line. No injuries or illnesses have been reported.
Healthcare facilities and individuals using units from the affected lot should contact their medical device supplier or Becton Dickinson directly for return or replacement instructions.
The recalled product
- Product
- BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 54,010
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)
- GTIN: 382903949007 Lot Numbers/Exp.Date: 1214380 7/31/2024
Distribution
Part of a larger recall action
This product is one of 11 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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