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Recall Observatory FDA recall evidence

Device product

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

Z-1236-2020

December 20, 2019

Class II

Product summary

Firm
Arrow International Inc
Event
Event 84688
Status
Terminated
Classification
Class II
Quantity
250 units
Official record key
device-enforcement:Z-1236-2020

Official wording

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

Code information: Lot Number: 13F18A0527

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