Z-1440-2022 Class II Ongoing

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

FDA device recall Z-1440-2022 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: 40,050.

Recall Details

Product Type
Devices
Report Date
Jul 27, 2022
Initiation Date
May 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40,050

Product Description

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (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: 382903836871 Lot Numbers/Exp.Date: 1082428 3/31/2024 1097856 3/31/2024 1111860 4/30/2024 1188909 6/30/2024 1208182 7/31/2024 1179403 6/30/2024

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1440-2022
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.