Agency classClass IIOur severity:High FDA (Devices)·Z-1431-2022·Announced 2022-07-27

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Infusion / IV Component
Hazard: fluid-leakage
biohazard-exposure
under-dosing
contamination
air-ingress
Affected units: 485,000

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

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.

See all 11 products in this recall →

Same manufacturer · Becton Dickinson & Company

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