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Recall Observatory FDA recall evidence

Device product

Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664

Z-2042-2019

April 30, 2019

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 82927
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2042-2019

Official wording

Reason: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Code information: Lot Number: 905657, 906327, 906341

Distribution pattern: Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing defect