Z-1438-2022 Class II Ongoing
FDA device recall Z-1438-2022 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: 448,040.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- May 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 448,040
Product Description
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (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: 382903950003 Lot Numbers/Exp.Date: 1120604 3/31/2024 1098929 3/31/2024 1123643 4/30/2024 1063423 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-1438-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026