Saranas recalls Early Bird Bleed Monitoring System Introducer Sheath Sets with design error causing device to fail self-tests. Users must check device function before use as per updated instructions.
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Saranas is recalling specific models of their Early Bird Bleed Monitoring System Introducer Sheath Sets due to a design error that prevents the device from powering on and completing self-tests. This means users must verify the device works properly before each use to avoid potential issues.
The device has a design error that prevents it from powering on and completing the necessary self-tests. This means the device may not function correctly as intended, potentially leading to inaccurate monitoring results if not properly checked before use.
Users of the Early Bird Bleed Monitoring System Introducer Sheath Sets with the specified model numbers and lot codes are affected. Healthcare professionals using these devices for medical monitoring are most at risk.
Check for model numbers FG001-01 (6F) or FG001-02 (8F) with lot codes listed in the recall notice. The product was sold with specific UDI/REF/Lot numbers provided in the recall details.
Verify the device powers on and completes self-tests before each use as per updated instructions.
The device has a design error causing it to fail self-tests, so users must check it functions properly before each use.
FG001-01 (6F) and FG001-02 (8F) with specific lot codes listed in the recall notice.
No, but you must check the device functions properly before each use as per updated instructions.
We’ve drafted a message you can send Saranas to request your refund or repair — edit it as you like.
Subject: Recall Z-1684-2022 — Saranas Saranas Hello, I own a Saranas that is covered by recall Z-1684-2022 from Saranas. 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.
