Home / Recalls / Resource Optimization & Innovation LLC / Z-0950-2022

Z-0950-2022 Class II Terminated

Recalled by Resource Optimization & Innovation LLC — Saint Louis, MO

Recall Details

Product Type
Devices
Report Date
April 27, 2022
Initiation Date
February 28, 2022
Termination Date
May 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,570 kits

Product Description

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Reason for Recall

A kit component, the PDI Prevantics Swab, was recalled.

Distribution Pattern

US distribution to two consignees located in Missouri

Code Information

a. Manufacturer Item 303403REG; UDI: 20326053105252 Batch/Lot Number 272394, 272723, 273243, 274119, 274222, 275120, 275700, 276890, 277198, 277650, 278195, 278702, 278984, 279240, 279592, 281107, 282148, 282546, 283355, 283758, 283985, 284757, 285260, 286471, 287025, 287757, 287995, 288331, 288535, 289809, 290876, 291283, 292384 b. Manufacturer Item 303404REG; UDI: 20326053105269 Batch/Lot Number 272920, 273244, 273589, 273982, 275005, 275462, 276185, 276898, 277665, 279246, 279597, 283768, 284492, 285144, 285594, 286503, 287537, 288105, 281116, 281378, 281951, 282860, 288553, 288990, 289829, 290601 c. Manufacturer Item 57931 Batch/Lot Number 273102, 275515, 276078, 276342, 277476, 279353, 281577, 282456, 283231, 283246, 284704, 289997, 288248

Other recalls by Resource Optimization & Innovation LLC

  • 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-1652-2017 Class II — Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn (January 9, 2017)
  • Z-1675-2017 Class II — Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa (January 9, 2017)
  • Z-1553-2017 Class II — Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hill (January 9, 2017)
  • Z-1589-2017 Class II — Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills (January 9, 2017)
  • Z-1635-2017 Class II — Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla (January 9, 2017)
  • Z-1608-2017 Class II — Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center (January 9, 2017)