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FDA (Device enforcement)Recalled 2022-05-09class ii

Becton Dickinson & Company: BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

Is my product affected?

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

  • UPC 382903946020

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling BD Connecta Stopcock Without Extension Tube (Catalog No. 394602) due to a potential leakage hazard at the housing component. This leakage could result in treatment delays or interruptions, exposure to infusate and biohazardous materials, under-dosing or under-infusion of medication, contamination, and/or air entering the system. Approximately 2.1 million units are affected, with distribution occurring worldwide including across most U.S. states and multiple Asian and European countries.

The affected products include multiple lot numbers with expiration dates ranging from January 31, 2024 through May 31, 2024. The product identification number is GTIN 382903946020. The recall notice does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 2,100,210 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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