BD Connecta Stopcock with OFF Directed Tap Without… recallZ-1431-2022 · Becton Dickinson & Company · initiated May 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
FDA root cause category: Under Investigation by firm
What the company is doing
BD notified consignees Medical Device Field Correction Notice on 5/9/22 via mail/email. Firm issued Urgent Medical Device Field Correction Letter extended to additional lots on July 13, 2022 via email. Letter states reason for recall, health risk and action to take: Please Take the Following Actions: 1. Inspect your inventory, locate and quarantine any units of the impacted lot numbers and destroy all affected product. 2. For Clinical Users: For devices in situ, check to see if the device is within scope of this Field Safety Notice and replace immediately. If you are unable to determine if the device is within scope, replace the device or continue to monitor for leakage and/or other complications. 3. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. North American Regional Complaint Center 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT for [email protected] General Follow-up, Product Complaints, Technical Questions
Recall details
- Recall number
- Z-1431-2022
- Status
- Open, Classified
- Initiated by the company
- May 9, 2022
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 485,000 units
- Product code
- FMG
- FDA submissions
- K974083
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of 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 the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.
Product description
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Code information (models, lots, serial numbers)
UDI: 382903949106 Lot Number/Exp Date: 1154844 5/31/2024 1098945 3/31/2024 1098944 3/31/2024 1098943 3/31/2024 1061533 2/29/2024 1061535 2/29/2024 1061531 2/29/2024 1061526 2/29/2024 1061527 2/29/2024 1061528 2/29/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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