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Recall Observatory FDA recall evidence

Device product

BD Microtainer SST Part/Catalog No.365967

Z-0056-2020

May 13, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82851
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0056-2020

Official wording

Reason: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Code information: Lot Number/UDI: 8094573 (01)30382903659679 (17)190630(10)8094573(30)50 (17)190630(10)8094573(30)200 (01)50382903659673 8094575 (01)30382903659679 (17)190630(10)8094575(30)50 (17)190630(10)8094575(30)200 (01)50382903659673 8094578 (01)30382903659679 (17)190630(10)8094578(30)50 (17)190630(10)8094578(30)200 (01)50382903659673 8117697 (01)30382903659679 (17)190731(10)8117697(30)50 (17)190731(10)8117697(30)200 (01)50382903659673 8165883 (01)30382903659679 (17)190831(10)8165883(30)50 (17)190831(10)8165883(30)200 (01)50382903659673 8165884 (01)30382903659679 (17)190831(10)8165884(30)50 (17)190831(10)8165884(30)200 (01)50382903659673 8170911 (01)30382903659679 (17)190831(10)8170911(30)50 (17)190831(10)8170911(30)200 (01)50382903659673 8171861 (01)30382903659679 (17)190831(10)8171861(30)50 (17)190831(10)8171861(30)200 (01)50382903659673 8220937 (01)30382903659679 (17)191031(10)8220937(30)50 (17)191031(10)8220937(30)200 (01)50382903659673 8220938 (01)30382903659679 (17)191031(10)8220938(30)50 (17)191031(10)8220938(30)200 (01)50382903659673 8282848 (01)30382903659679 (17)191231(10)8282848(30)50 (17)191231(10)8282848(30)200 (01)50382903659673 8284571 (01)30382903659679 (17)191231(10)8284571(30)50 (17)191231(10)8284571(30)200 (01)50382903659673 8284574 (01)30382903659679 (17)191231(10)8284574(30)50 (17)191231(10)8284574(30)200 (01)50382903659673

Distribution pattern: Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.