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Recall Observatory FDA recall evidence

Device product

MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

Z-0202-2023

August 19, 2022

Class III

Product summary

Firm
Canadian Hospital Specialties
Event
Event 90926
Status
Terminated
Classification
Class III
Quantity
9100 units
Official record key
device-enforcement:Z-0202-2023

Official wording

Reason: Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.

Code information: UDI/DI: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.