Home / Recalls / Resource Optimization & Innovation Llc / Z-1548-201

Z-1548-201 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
2,122 kits

Product Description

Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

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

029388C Exp Date: 2017-11-09; 030253C Exp Date: 2017-12-30; 032103C Exp Date: 2018-03-07; 033169C Exp Date: 2018-04-26; 034466C Exp Date: 2018-06-22;

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 (February 28, 2022)
  • 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-1649-2017 Class II — Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn (January 9, 2017)
  • Z-1553-2017 Class II — Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hill (January 9, 2017)
  • Z-1585-2017 Class II — Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn (January 9, 2017)
  • Z-1589-2017 Class II — Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills (January 9, 2017)
  • Z-1595-2017 Class II — Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hil (January 9, 2017)