Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Reported: May 3, 2023 Initiated: March 22, 2023 #Z-1434-2023
Product Description
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Reason for Recall
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 322 kits
- Distribution
- US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.. Recalled by ROi CPS LLC. Units affected: 322 kits.
Why was this product recalled? ▼
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1434-2023.
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