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Recall Observatory FDA recall evidence

Device product

BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.

Z-0193-2020

July 31, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 83507
Status
Terminated
Classification
Class II
Quantity
1735600 units
Official record key
device-enforcement:Z-0193-2020

Official wording

Reason: Separation of front and rear barrels upon activation of the safety feature that retracts the needle

Code information: Lot / Serial Number. 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 9115965 9115913

Distribution pattern: Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Separation of front and rear barrels upon activation of the safety feature that retracts the needle