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Recall Observatory FDA recall evidence

Device product

Rusch EasyCath Kit

Z-2086-2019

July 01, 2019

Class II

Product summary

Firm
Teleflex Medical
Event
Event 83250
Status
Terminated
Classification
Class II
Quantity
3,700 devices
Official record key
device-enforcement:Z-2086-2019

Official wording

Reason: Potential for product not to be sterile.

Code information: Catalog Number ECK120, Lot Number 74C1900304, Expiration Date 03/01/2022. Catalog Number ECK125, Lot Number 74B1901676, Expiration Date 06/01/2022.

Distribution pattern: Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for product not to be sterile.