Home / Recalls / Resource Optimization & Innovation Llc / Z-1556-2017

Z-1556-2017 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

Recall Details

Product Type
Devices
Report Date
April 5, 2017
Initiation Date
January 9, 2017
Termination Date
September 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46 kits

Product Description

Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels

Reason for Recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Distribution Pattern

US Distribution to LA and TX.

Code Information

034433C Exp Date 2018-06-21; 039905C Exp Date 2018-12-01; 040125C Exp Date 2018-12-08;

Other recalls by Resource Optimization & Innovation Llc

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  • Z-2699-2020 Class II — regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576RE (June 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 Fl (May 4, 2020)
  • Z-0169-2018 Class II — Regard Custom Surgical Pack Packs contain surgical instruments and accessorie (September 25, 2017)
  • Z-1634-2017 Class II — Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Cent (January 9, 2017)
  • Z-1551-2017 Class II — Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn (January 9, 2017)
  • Z-1615-2017 Class II — Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center S (January 9, 2017)
  • Z-1590-2017 Class II — Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills (January 9, 2017)
  • Z-1633-2017 Class II — Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Cent (January 9, 2017)