Home / Recalls / Resource Optimization & Innovation Llc / Z-1655-2017

Z-1655-2017 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
288 kits

Product Description

Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy 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

028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20

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  • 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-1548-201 Class II — Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn (January 9, 2017)
  • Z-1565-2017 Class II — Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU (January 9, 2017)
  • Z-1657-2017 Class II — Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn (January 9, 2017)
  • Z-1598-2017 Class II — Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills (January 9, 2017)
  • Z-1574-2017 Class II — Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU (January 9, 2017)