ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
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.
Read the official notice →- Date
- 2023-05-03
- Country
- United States
- Brand
- ROi CPS
- Product
- Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL and MO. There was no…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
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