BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Summary
The FDA issued a Class II for BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (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-1433-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Lot/Code Info: 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
Quantity Affected: 1,960,360
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-1433-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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