Home / Recalls / Resource Optimization & Innovation Llc / Z-0187-2016

Z-0187-2016 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

FDA device recall Z-0187-2016 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: 153 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: 153 kits

Product Description

Regard, Item Number 830054001, CV00625A - 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

22404, 23406, 23642, and 24032

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0187-2016
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.

Other recalls by Resource Optimization & Innovation Llc

Z-0950-2022 Class II — Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous… (Feb 28, 2022)
Z-2699-2020 Class II — regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER #… (Jun 17, 2020)
Z-2369-2020 Class II — Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush… (May 4, 2020)
Z-2368-2020 Class II — Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline… (May 4, 2020)
Z-0169-2018 Class II — Regard Custom Surgical Pack Packs contain surgical instruments and… (Sep 25, 2017)
Z-1575-2017 Class II — Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU (Jan 9, 2017)
Z-1664-2017 Class II — Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn (Jan 9, 2017)
Z-1585-2017 Class II — Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn (Jan 9, 2017)
Z-1595-2017 Class II — Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover… (Jan 9, 2017)
Z-1587-2017 Class II — Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper (Jan 9, 2017)