Z-1435-2022 Class II Ongoing
FDA device recall Z-1435-2022 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.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- May 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
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
GTIN: 382903946051 Lot Numbers/Exp.Date: 1133181 4/30/2024 1117434 3/31/2024 1110835 3/31/2024 1119671 3/31/2024 1098353 3/31/2024 1098351 3/31/2024 1098350 3/31/2024 1110839 3/31/2024 1110842 3/31/2024 1067265 2/29/2024 1067268 2/29/2024 1067274 2/29/2024 1063372 2/29/2024 1067273 2/29/2024 1067264 2/29/2024 1034587 1/31/2024 1040899 1/31/2024 1034590 1/31/2024 1034594 1/31/2024 1040902 1/31/2024 1040891 1/31/2024 1034597 1/31/2024 1060806 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-1435-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026