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Recall Observatory FDA recall evidence

Device product

Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.

Z-0184-2016

August 25, 2015

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 72052
Status
Terminated
Classification
Class II
Quantity
84 kits
Official record key
device-enforcement:Z-0184-2016

Official wording

Reason: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

Code information: 23076, 25396, 26210, and 27186

Distribution pattern: Distributed in Texas and Louisiana.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.