GETINGE Atrium 2100 mL chest drain systems recalled due to temperature excursions between June 1 and September 30, 2021. Product may have been affected by higher temperatures during shipping, potentially reducing 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.
GETINGE's Atrium 2100 mL chest drain systems were recalled because they were exposed to higher temperatures between June 1 and September 30, 2021. This could have reduced the product's effectiveness. Affected units were shipped during this period and may need evaluation by healthcare providers.
The chest drain systems were exposed to higher temperatures during shipping from June 1 to September 30, 2021. This temperature exposure could have reduced the product's effectiveness, potentially impacting medical procedures.
Healthcare facilities that received the GETINGE Atrium 2100 mL chest drain systems between June 1 and September 30, 2021. Medical staff using these systems are most at risk if the product's effectiveness is compromised.
Check for the model number 2002-000 on the GETINGE Atrium 2100 mL chest drain system. Units shipped between June 1 and September 30, 2021 are affected.
Verify the model number 2002-000 and shipping dates between June 1 and September 30, 2021.
The GETINGE Atrium 2100 mL chest drain systems were recalled because they were exposed to higher temperatures between June 1 and September 30, 2021, which may have reduced product effectiveness.
Check if your unit has the model number 2002-000 and was shipped between June 1 and September 30, 2021. Contact GETINGE for further guidance.
The recall record does not mention a specific remedy or fix for this issue.
We’ve drafted a message you can send GETINGE to request your refund or repair — edit it as you like.
Subject: Recall Z-1607-2022 — GETINGE GETINGE Hello, I own a GETINGE that is covered by recall Z-1607-2022 from GETINGE. 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.
