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Recall Observatory FDA recall evidence

Device product

JUDKINS PACK

Z-1256-2021

February 11, 2021

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 87343
Status
Terminated
Classification
Class II
Quantity
298 units
Official record key
device-enforcement:Z-1256-2021

Official wording

Reason: Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.

Code information: Model SANHDJTVCF, lot 525067.

Distribution pattern: US state of VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.