StayFIX Percutaneous Catheter Fixation Device Recalled Due to Storage Temperature Exposure
MERIT MEDICAL SYSTEMS StayFIX catheter fixation devices recalled due to facility temperature excursions during storage before delivery. Approximately 109 units received between June-September 2021; manufacturer states no adverse health consequences are likely.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III precautionary recall due to storage temperature excursions with no reported illnesses or injuries. The manufacturer explicitly states the temperature deviation is not likely to cause adverse health consequences.
Plain-English summary
The MERIT MEDICAL SYSTEMS StayFIX Percutaneous Catheter Fixation Device (Model 884450023358) is being recalled due to facility temperature excursions that occurred between June and August 2021 prior to product delivery.
The device is used to secure anesthesia catheters during medical procedures. Approximately 109 units distributed nationwide that were received between June 1 and September 30, 2021, may have been exposed to higher-than-recommended temperatures during storage.
The manufacturer states that exposure to these temperatures is not likely to cause adverse health consequences. No illnesses or injuries have been reported.
This is a Class III recall issued by the FDA.
The recalled product
- Product
- MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN: 00884450023358
- 10884450023355
- 20884450023352
Distribution
Distributed nationwide across the United States.
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