Merit Medical Systems recalls Aspira Dressing Kit (Model 4991503) and Aspira Pleural/Peritoneal Drainage Kit (Model 4992301) due to temperature exposure during shipping from June to August 2021, potentially reducing product effectiveness.
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.
Merit Medical Systems is recalling two medical kits because they were exposed to higher temperatures during shipping from June to August 2021. This could make the products less effective, especially if used in medical settings where precise function is critical.
The kits were exposed to higher temperatures during shipping from June to August 2021, which could reduce their effectiveness. This is a risk for medical facilities that rely on these products for critical care, as less effective kits might not function properly during procedures.
Healthcare facilities that received the Aspira Dressing Kit (Model 4991503) or Aspira Pleural/Peritoneal Drainage Kit (Model 4992301) between June 1 and September 30, 2021. Medical staff using these kits are most at risk if the products are less effective.
Check for the Aspira Dressing Kit with Model Number 4991503 or the Aspira Pleural/Peritoneal Drainage Kit with Model Number 4992301. These were shipped between June 1 and September 30, 2021, with specific GTIN codes listed in the recall notice.
Identify if your kit has Model Number 4991503 or 4992301, as these were affected by temperature exposure during shipping from June to August 2021.
The Aspira Dressing Kit and Aspira Pleural/Peritoneal Drainage Kit were exposed to higher temperatures during shipping from June to August 2021, which could reduce their effectiveness.
The recall notice does not specify a remedy, so you should check with your healthcare facility to determine if the product is still effective.
Yes, the affected products were shipped between June 1 and September 30, 2021.
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-1599-2022 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1599-2022 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.
