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, and the hazard is a labeling error (size mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Baxter Healthcare Corporation is recalling 386 units of GEM Microvascular Anastomotic Coupler Devices. The recall is due to a labeling discrepancy where the coupler size indicated on the outer tray may not match the size indicated on the inner tray.
These devices are intended for use in the anastomosis of veins and arteries in microsurgical procedures within the peripheral vascular system. The affected product code is 5111-00250-060, and the specific lots involved are SP19J11-1402242, SP19J11-1402246, and SP19J11-1402265.
The devices were distributed nationwide in the United States and in various countries including Saudi Arabia, Italy, Austria, Argentina, Japan, Israel, Spain, South Africa, Greece, Australia, France, Sweden, the Netherlands, the UK, Germany, and Canada. Healthcare providers should stop using these devices and contact Baxter Healthcare for further instructions.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 386
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 (5)
- Product Code 5111-00250-060
- GEM2753
- Lots SP19J11-1402242
- SP19J11-1402246
- and SP19J11-1402265
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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