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FDA (Device enforcement)Recalled 2019-07-17closedclass ii

Becton Dickinson & Co.: Kit BD Max Vaginal Panel; Catalog # 443712

Is my product affected?

Kit BD Max Vaginal Panel; Catalog # 443712

  • UPC 00382904437121

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

What happened

Becton Dickinson & Co. is recalling the BD MAX Vaginal Panel (Catalog # 443712) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The recall affects 666 units across three lots (Lot #9092737, #9092738, and #9127920), all with an expiration date of March 21, 2020. The affected product was distributed to numerous U.S. states including California, Texas, Florida, New York, and many others, as well as internationally to countries including Canada, Australia, Brazil, Japan, and Singapore.

The source document does not specify a remedy or recommended action for consumers who have this product.

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

Hazard

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Details from the source

Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan Quantity: 666 units Lot/code info: Lot # 9092737; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092737(30)1; Exp : 3/21/2020 Lot # 9092738; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092738(30)1; Exp :3/21/2020 Lot # 9127920; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9127920(30)1; Exp : 3/21/2020

Source

Official record: FDA (Device enforcement) ↗

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

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