Baxter GEM Flowcoupler Recall Due to Packaging Puncture Risk
Baxter Healthcare is recalling 315 units of GEM Flowcoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the specific hazard is a packaging defect (booklet puncturing the lid) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling 315 units of the GEM Flowcoupler, 2.0 mm, sterile, 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 packaging defect where the instructions for use booklet may puncture the outer Tyvek lid.
The affected units are identified by lot codes SP15H05-1067843 through SP15K05-1094463. These devices were distributed nationwide in the United States as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada. The agency has classified this as a Class II recall.
Healthcare providers and patients should stop using the affected GEM Flowcoupler devices and contact Baxter Healthcare for further instructions or a replacement. The hazard is limited to the potential for the packaging to be compromised by the included booklet, which may affect the sterility or integrity of the device packaging.
The recalled product
- Product
- GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-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…
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 315
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)
- SP15H05-1067843 thru SP15K05 -1094463
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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