Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Reported: May 3, 2023 Initiated: March 22, 2023 #Z-1435-2023
Product Description
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
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
- 386 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: 800753005, GY00958E - WPH GYN Laparoscopy Pack.. Recalled by ROi CPS LLC. Units affected: 386 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-1435-2023.
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