Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch
Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a labeling mismatch, which is a moderate risk compared to direct contamination or structural failure.
Plain-English summary
Baxter Healthcare Corporation is recalling GEM Microvascular Anastomotic Coupler Devices. These devices are intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
The recall is being issued because the Coupler size labeling of the outer tray may not match the Coupler size labeling of the inner tray. This discrepancy could lead to the use of an incorrect device size during microsurgical procedures.
The affected products are identified by Product Code 511-00200-010; GEM2752, and Lots SP19J09-1401617 and SP19J08-1401480. The devices were distributed worldwide, including nationwide in the United States and in several international countries. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code 511-00200-010
- GEM2752
- Lots SP19J09-1401617 and SP19J08-1401480
Distribution
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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