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Recall Observatory FDA recall evidence

Device product

AVID Medical QA Pack AV10654-10

Z-0581-2018

July 03, 2017

Class II

Product summary

Firm
Avid Medical, Inc.
Event
Event 79135
Status
Terminated
Classification
Class II
Quantity
330
Official record key
device-enforcement:Z-0581-2018

Official wording

Reason: The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.

Code information: Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)

Distribution pattern: Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.