Skip to content
Recall Observatory FDA recall evidence

Device product

Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

Z-0273-2020

July 18, 2019

Class II

Product summary

Firm
Thermo Fisher Scientific (Monterrey)
Event
Event 83762
Status
Terminated
Classification
Class II
Quantity
514,200 each
Official record key
device-enforcement:Z-0273-2020

Official wording

Reason: Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Code information: Lot # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504

Distribution pattern: OH

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    plastic shavings