Device product

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

Z-0054-2020

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-0054-2020

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: 8117750 (01)30382903659631 (17)191031(10)8117750(30)50 (17)191031(10)8117750(30)200 (01)50382903659635 8155792 (01)30382903659631 (17)191130(10)8155792(30)50 (17)191130(10)8155792(30)200 (01)50382903659635 8223778 (01)30382903659631 (17)200131(10)8223778(30)50 (17)200131(10)8223778(30)200 (01)50382903659635 8223779 (01)30382903659631 (17)200131(10)8223779(30)50 (17)200131(10)8223779(30)200 (01)50382903659635 8268514 (01)30382903659631 (17)200229(10)8268514(30)50 (17)200229(10)8268514(30)200 (01)50382903659635

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.