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Z-0186-2016 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

FDA device recall Z-0186-2016 was initiated by Resource Optimization & Innovation Llc on Aug 25, 2015 and is designated Class II. Reason for recall: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. The recall status is terminated (terminated Apr 6, 2017). Affected quantity: 77 kits.

Recall Details

Product Type: Devices
Report Date: Nov 4, 2015
Initiation Date: Aug 25, 2015
Termination Date: Apr 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 77 kits

Product Description

Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

Reason for Recall

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

Distribution Pattern

Distributed in Texas and Louisiana.

Code Information

24641

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0186-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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