Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Reported: July 27, 2022 Initiated: June 3, 2022 #Z-1407-2022
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.
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 86 kits
- Distribution
- Distribution was made to MO. There was no foreign/military/government distribution.
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.. Recalled by ROi CPS LLC. Units affected: 86 kits.
Why was this product recalled? ▼
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1407-2022.
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