Z-1433-2022 Class II Ongoing

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

FDA device recall Z-1433-2022 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: 1,960,360.

Recall Details

Product Type
Devices
Report Date
Jul 27, 2022
Initiation Date
May 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,960,360

Product Description

BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (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: 382903946013 Lot Numbers/Exp.Date: 1126398 4/30/2024 1127180 4/30/2024 1127179 4/30/2024 1123685 4/30/2024 1119049 3/31/2024 1126395 4/30/2024 1123679 4/30/2024 1098302 3/31/2024 1123674 4/30/2024 1098301 3/31/2024 1123683 4/30/2024 1123682 4/30/2024 1123670 4/30/2024 1098294 3/31/2024 1098278 3/31/2024 1098283 3/31/2024 1098276 3/31/2024 1090041 2/29/2024 1089729 2/29/2024 1089723 2/29/2024 1098266 3/31/2024 1098272 3/31/2024 1090046 2/29/2024 1090043 2/29/2024 1061602 2/29/2024 1061605 2/29/2024 1033538 1/31/2024 1033511 1/31/2024 1033539 1/31/2024 1033514 1/31/2024 1034769 1/31/2024 1033518 1/31/2024 1034649 1/31/2024 1061584 2/29/2024 1061594 2/29/2024 1061601 2/29/2024 1033510 1/31/2024 1033541 1/31/2024 1033542 1/31/2024 1034656 1/31/2024 1040916 1/31/2024 1061596 2/29/2024 1061598 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-1433-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.