BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage
BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. However, it presents a risk of serious harm to patients requiring infusion therapy through potential leakage causing treatment interruption, biohazardous exposure, and under-dosing, meeting the criterion for High severity.
Plain-English summary
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (Catalog No. 394910) is being recalled by Becton Dickinson & Company. A total of 485,000 units have been distributed.
The stopcock housing component may develop leakage. This can result in delay or interruption of treatment, exposure to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress into the infusion line.
The recalled product has been distributed worldwide, including to patients and healthcare facilities in the United States (AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV) and internationally in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. Affected lot numbers with expiration dates include 1154844 (5/31/2024), 1098945, 1098944, and 1098943 (3/31/2024), among others.
The recalled product
- Product
- BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
- Manufacturer
- Becton Dickinson & Company
- Hazard
- fluid-leakage
- biohazard-exposure
- under-dosing
- contamination
- air-ingress
Distribution
Distributed nationwide across the United States.
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