Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Summary
The FDA issued a Class II for Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) by Becton Dickinson & Company. Reason: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate an.
Details
Source
Device Recall
External ID
Z-1440-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Lot/Code Info: 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
Quantity Affected: 40,050
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-09
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1440-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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