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

Becton Dickinson & Company: BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

Is my product affected?

BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

  • UPC 382903950003

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

What happened

Becton Dickinson & Company is recalling BD Connecta White 360 Shelf products (catalog number 395000) distributed worldwide because the stopcock housing component may leak. This leakage could delay or interrupt medical treatment, expose patients to infusate and biohazardous material, result in under-dosing or under-infusion, cause contamination, or allow air to enter the system. A total of 448,040 units are affected, with specific lot numbers and expiration dates ranging from February 2024 to April 2024.

The affected products were distributed nationwide across 31 U.S. states and in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The source document does not specify a remedy or action for consumers to 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: 448,040 Lot/code info: GTIN: 382903950003 Lot Numbers/Exp.Date: 1120604 3/31/2024 1098929 3/31/2024 1123643 4/30/2024 1063423 2/29/2024

Source

Official record: FDA (Device enforcement) ↗

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

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