Z-1407-2022 Class II Terminated
FDA device recall Z-1407-2022 was initiated by ROi CPS LLC on Jun 3, 2022 and is designated Class II. Reason for recall: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. The recall status is terminated (terminated Apr 14, 2023). Affected quantity: 86 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 3, 2022
- Termination Date
- Apr 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 kits
Product Description
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Reason for Recall
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Distribution Pattern
Distribution was made to MO. There was no foreign/military/government distribution.
Code Information
(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1407-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026