Medivance Inc. recalls Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air…
Read the official notice →- Date
- 2024-08-07
- Country
- United States
- Brand
- Medivance
- Product
- Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of IN, OK, MO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Medivance recalls
- 2024-04-03
USMedivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice →
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- 2024-08-07
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