Device product

Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

Z-0187-2016

August 25, 2015

Class II

Product summary

Firm: Resource Optimization & Innovation Llc
Event: Event 72052
Status: Terminated
Classification: Class II
Quantity: 153 kits
Official record key: device-enforcement:Z-0187-2016

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: 22404, 23406, 23642, and 24032

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.