Merit Medical Systems recalls StayFix Fixation Devices (model 884450023358) due to potential temperature excursions during shipping from June to August 2021. This may affect product effectiveness but is unlikely to cause health issues.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Merit Medical Systems is recalling StayFix Fixation Devices with model number 884450023358 that were shipped between June 1, 2021 and September 30, 2021. These devices may have been exposed to higher temperatures during shipping, which could reduce their effectiveness but are unlikely to cause health problems.
The devices may have been exposed to higher temperatures during shipping from June to August 2021, which could reduce their effectiveness. However, the recall states this is unlikely to cause health consequences.
Healthcare facilities that received these devices between June 1, 2021 and September 30, 2021 are likely affected. Staff using these devices for anesthesia catheter fixation are at risk if the device was exposed to higher temperatures during shipping.
Check for the model number 884450023358 on the device. These devices were shipped between June 1, 2021 and September 30, 2021. The product is used to secure anesthesia catheters.
Look for the model number 884450023358 on the StayFix Fixation Device.
No, the recall states that this device with the specific storage temperature deviation is unlikely to cause health issues.
The recall covers devices shipped between June 1, 2021 and September 30, 2021.
The recall does not specify a remedy, so no action is required beyond checking the model number.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1797-2022 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1797-2022 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
