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Recall Observatory FDA recall evidence

Device product

BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

Z-0745-2017

August 08, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 75252
Status
Ongoing
Classification
Class II
Quantity
1,788,150 units
Official record key
device-enforcement:Z-0745-2017

Official wording

Reason: BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

Code information: 5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650

Distribution pattern: Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.