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Recall Observatory FDA recall evidence

Device product

Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

Z-1242-2020

December 20, 2019

Class II

Product summary

Firm
Arrow International Inc
Event
Event 84688
Status
Terminated
Classification
Class II
Quantity
410
Official record key
device-enforcement:Z-1242-2020

Official wording

Reason: Product lidstock contains the incorrect expiration date for the product

Code information: Lot Number: 13F18G0475 13F18F0729

Distribution pattern: Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product lidstock contains the incorrect expiration date for the product