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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Baxter Healthcare Corporation: 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

Agency Publication Date: April 8, 2020
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Affected Products

Product: GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

Product Code 5111-00250-060; GEM2753; Lots SP19J11-1402242; SP19J11-1402246; and SP19J11-1402265

Lot Numbers:
5111-00250-060
Product: GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

Product Code 5111-00200-060; GEM2752; Lots SP19J08-1401476 and SP19J09-1401614

Lot Numbers:
5111-00200-060
Product: GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

Product Code 511-00200-010; GEM2752; Lots SP19J09-1401617 and SP19J08-1401480

Lot Numbers:
511-00200-010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85103
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 2 products (386 units; 209 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.