Baxter recalls GEM Microvascular Anastomotic Coupler Devices due to potential size labeling mismatch between outer and inner trays, which could lead to improper use during microsurgery.
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 Anastom: Coupler Devices that may have mismatched size labels between the outer and inner trays. This mismatch could cause improper use during delicate microsurgical procedures, potentially leading to complications.
The outer tray size label may not match the inner tray size label. This mismatch could lead to using the wrong size device during microsurgery, potentially causing complications in vein and artery anastomosis.
Healthcare professionals using these devices for microsurgery are most at risk. Patients undergoing procedures with these devices may be affected if the mismatch causes improper use.
Check for product code 5111-00200-060, model GEM2752, and lots SP19J08-1401476 or SP19J09-1401614. These devices are intended for use in microsurgical procedures on veins and arteries.
Verify that the outer tray size label matches the inner tray size label before use.
The recall is due to potential size labeling mismatch between the outer and inner trays, which could lead to improper use during microsurgical procedures.
Product code 5111-00200-060.
Check for product code 5111-00200-060, model GEM2752, and lots SP19J08-1401476 or SP19J09-1401614.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1686-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1686-2020 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.
