Z-1431-2022 Class II Ongoing
FDA device recall Z-1431-2022 was initiated by Becton Dickinson & Company on May 9, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 485,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- May 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 485,000 units
Product Description
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1431-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026