Z-1051-2022 Class II Terminated
FDA device recall Z-1051-2022 was initiated by ROi CPS LLC on Mar 21, 2022 and is designated Class II. Reason for recall: Kits were packed into shipping boxes incorrectly. The recall status is terminated (terminated Dec 28, 2023). Affected quantity: 85 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Mar 21, 2022
- Termination Date
- Dec 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 kits
Product Description
Regard brand CABG Pack A and B - Spartanburg
Reason for Recall
Kits were packed into shipping boxes incorrectly.
Distribution Pattern
Recall impacted one domestic consignee in NC
Code Information
Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1051-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026