Home / Recalls / Resource Optimization & Innovation Llc / Z-1645-2017

Z-1645-2017 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

FDA device recall Z-1645-2017 was initiated by Resource Optimization & Innovation Llc on January 9, 2017 and is designated Class II. 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. The recall status is terminated (terminated September 28, 2018). Affected quantity: 1224 kits.

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
1224 kits

Product Description

Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole 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

034494C Exp Date 2018-06-25; 037642C Exp Date 2018-08-25; 038956C Exp Date 2018-10-19; 040142C Exp Date 2018-12-09

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-1628-2017 Class II — Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa R (January 9, 2017)
  • Z-1652-2017 Class II — Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn (January 9, 2017)
  • Z-1657-2017 Class II — Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn (January 9, 2017)
  • Z-1675-2017 Class II — Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa (January 9, 2017)
  • Z-1635-2017 Class II — Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla (January 9, 2017)

FDA data resources