Z-1434-2022Class II

BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

Name: Z-1434-2022 BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Creator: Becton Dickinson & Company
Published: 2022-05-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-05-09 / Open, Classified

FDA source

Becton Dickinson & Company began a recall of BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) on 2022-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1434-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-09
Posted: 2022-07-21
Recalling firm: Becton Dickinson & Co
Product: BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Product code: FMG Stopcock, I.V. Set
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.
FDA root cause: Under Investigation by firm
Action: BD notified consignees Medical Device Field Correction Notice on 5/9/22 via mail/email. Firm issued Urgent Medical Device Field Correction Letter extended to additional lots on July 13, 2022 via email. Letter states reason for recall, health risk and action to take: Please Take the Following Actions: 1. Inspect your inventory, locate and quarantine any units of the impacted lot numbers and destroy all affected product. 2. For Clinical Users: For devices in situ, check to see if the device is within scope of this Field Safety Notice and replace immediately. If you are unable to determine if the device is within scope, replace the device or continue to monitor for leakage and/or other complications. 3. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. North American Regional Complaint Center 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT for [email protected] General Follow-up, Product Complaints, Technical Questions
Quantity in commerce: 2,100,210
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.
Product codes and lots: GTIN: 382903946020 Lot Numbers/Exp.Date: 1152283 5/31/2024 1113643 3/31/2024 1120601 3/31/2024 1113657 3/31/2024 1098327 3/31/2024 1124487 4/30/2024 1098376 3/31/2024 1098372 3/31/2024 1097651 3/31/2024 1098181 3/31/2024 1098379 3/31/2024 1085636 2/29/2024 1085897 2/29/2024 1097647 3/31/2024 1061613 2/29/2024 1063398 2/29/2024 1090040 2/29/2024 1097641 3/31/2024 1097637 3/31/2024 1098371 3/31/2024 1090039 2/29/2024 1085895 2/29/2024 1063392 2/29/2024 1090052 2/29/2024 1061609 2/29/2024 1084430 2/29/2024 1061606 2/29/2024 1063402 2/29/2024 1063369 2/29/2024 1063367 2/29/2024 1063370 2/29/2024 1063390 2/29/2024 1063368 2/29/2024 1063389 2/29/2024 1063366 2/29/2024 1033529 1/31/2024 1040952 1/31/2024 1040913 1/31/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1434-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1432-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1433-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1434-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1435-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1436-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1437-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1438-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1439-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1440-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1441-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code FMG

K974083Class IIConnecta Plus 1 and Connecta Plus 3 2-Way and 3-Way StopcocksOhmeda Medical / cleared 1998-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)