Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk
Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.
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. The hazard involves a packaging defect (booklet puncturing the lid) which poses a risk to sterility but does not involve a direct structural defect or reported injuries, fitting the Moderate criteria for low-risk contamination or packaging issues.
Plain-English summary
Baxter Healthcare Corp. is recalling 288 units of the GEM FlowCOUPLER, 3.5 mm, sterile EO, single-use implantable device. The device is intended for end-to-end anastomosis of veins and arteries in microsurgical and vascular reconstructive procedures. The recall is due to a defect where the instructions for use booklet may puncture the outer Tyvek lid.
The affected units are identified by lot codes SPI5El2-1049760 through SPI5K10-1096019. The devices were distributed nationwide in the United States as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada.
Healthcare providers and consumers should stop using the affected GEM FlowCOUPLER devices and contact Baxter Healthcare Corp. for further instructions on return or replacement.
The recalled product
- Product
- GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical an
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 288
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 (1)
- SPI5El2-1049760 thru SPI5K10-1096019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corp. 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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