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: the outer and inner trays may have mismatched size labels, which could cause improper use during microsurgery. This risk is specific to medical professionals using the devices in vascular procedures.
The outer tray size label may not match the inner tray size label. This mismatch could lead to improper use during microsurgical procedures, potentially causing errors in vascular anastomosis.
Medical professionals who use the GEM Microvascular Anastomotic Coupler Devices for microsurgery in the peripheral vascular system. The risk is highest for those using the specific product lots mentioned in the recall.
Check for product code 511-00200-010, model GEM2752, and lots SP19J09-1401617 or SP19J08-1401480. These devices are intended for use in microsurgery on veins and arteries.
Verify the product code (511-00200-010), model (GEM2752), and lot numbers (SP19J09-1401617 or SP19J08-1401480) to confirm if the device is affected.
The outer tray size label may not match the inner tray size label, which could lead to improper use during microsurgical procedures.
Mismatched size labels could cause errors in vascular anastomosis during microsurgery, potentially affecting surgical outcomes.
Check for product code 511-00200-010, model GEM2752, and lot numbers SP19J09-1401617 or SP19J08-1401480.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1687-2020 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1687-2020 from Baxter. 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.
