Z-1295-2022 Class II Terminated
FDA device recall Z-1295-2022 was initiated by ROi CPS LLC on May 20, 2022 and is designated Class II. Reason for recall: A nonsterile component was packaged in a sterile convenience kit. The recall status is terminated (terminated May 2, 2023). Affected quantity: 180 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- May 20, 2022
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 kits
Product Description
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Reason for Recall
A nonsterile component was packaged in a sterile convenience kit.
Distribution Pattern
US Nationwide distribution in the state of FL.
Code Information
Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1295-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026