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Recall Observatory FDA recall evidence

Device product

Kit BD Max CT/GC/TV; Catalog # 442970

Z-2331-2019

July 17, 2019

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 83406
Status
Terminated
Classification
Class II
Quantity
913 units
Official record key
device-enforcement:Z-2331-2019

Official wording

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

Code information: Lot # 9080876; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9080876(30)1; Exp: 4/14/2020 Lot #9092733; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9092733(30)1; Exp: 4/14/2020 Lot #9092734; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9092734(30)1; Exp: 5/12/2020 Lot #9106875; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9106875(30)1; Exp: 5/12/2020

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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