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Recall Observatory FDA recall evidence

Device product

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

Z-2055-2018

February 13, 2018

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 79709
Status
Terminated
Classification
Class II
Quantity
9,568,900 total products
Official record key
device-enforcement:Z-2055-2018

Official wording

Reason: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

Code information: 1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018

Distribution pattern: US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube