Baxter recalls GEM Microvascular Anastomotic Coupler Devices due to potential size mismatch between outer and inner tray labels, which could lead to incorrect vein/artery anastomosis during surgery.
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Baxter is recalling GEM Microvascular Anastomotic Coupler Devices because the size labels on the outer and inner trays might not match. This mismatch could cause incorrect vein or artery connections during microsurgery, potentially leading to complications.
The outer tray size label may not match the inner tray size label. This mismatch could result in incorrect vein or artery connections during microsurgical procedures, potentially causing complications.
Healthcare professionals using these devices for microsurgery are most at risk. The recall affects specific product lots used in peripheral vascular procedures.
Check for product code 5111-00250-060, model GEM2753, and lots SP19J11-1402242, SP19J11-1402246, or SP19J11-1402265. These devices are used in microsurgery for vein and artery connections.
Verify the size labels on both the outer and inner trays match the product code and lot numbers listed in the recall notice.
The size labels on the outer tray may not match the inner tray, which could lead to incorrect vein or artery connections during microsurgery.
Product code 5111-00250-060, model GEM2753.
Lots SP19J11-1402242, SP19J11-1402246, and SP19J11-1402265.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1685-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1685-2020 from Baxter Healthcare. 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.
