Merit Medical Systems recalls Temno 14 Gauge Soft Tissue Biopsy Devices (Model T146) produced between June 2021 and August 2021 due to potential temperature excursions affecting product effectiveness. Consumers should check if their device was made during this period.
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 Temno 14 Gauge Soft Tissue Biopsy Devices (Model T146) that were produced between June 1 and September 30, 2021. These devices may have been affected by temperature changes during shipping, which could reduce their effectiveness.
The devices were shipped between June 2021 and August 2021 and may have experienced temperature fluctuations during transit. These temperature changes could potentially affect the device's effectiveness, meaning it might not work as intended for soft tissue biopsies.
Healthcare professionals and medical facilities that purchased the Temno 14 Gauge Soft Tissue Biopsy Devices (Model T146) between June 1 and September 30, 2021. Medical staff using these devices for biopsies may be at risk if the device's effectiveness is compromised.
Check if your device has the model number T146 and was purchased between June 1, 2021, and September 30, 2021. The product includes a GTIN number starting with 00884450444467 or similar variants.
Look for the model number T146 on the device or packaging to confirm it is part of the recall.
The devices were shipped between June 2021 and August 2021 and may have experienced temperature fluctuations during transit, which could affect their effectiveness.
Check if your device has the model number T146 and was purchased between June 1, 2021, and September 30, 2021. If it is part of the recall, contact Merit Medical Systems for further instructions.
The recall is due to potential reduced effectiveness from temperature issues, not a direct risk of injury. The hazard does not involve physical harm like cuts or fires.
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-1600-2022 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1600-2022 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.
