Baxter GEM FlowCoupler Recalled Due to Packaging Lid Puncture Risk
Baxter Healthcare is recalling 118 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 defect involves packaging integrity (booklet puncturing the lid) rather than a direct device malfunction or reported injury, aligning with the 'Moderate' criteria for minor labeling/packaging issues or low-risk contamination.
Plain-English summary
Baxter Healthcare Corp. is recalling 118 units of the GEM FlowCoupler, a single-use implantable device used 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 of the packaging.
The affected products are identified by lot codes SPI5E12-1049765 through SPl5Hl8-1071450. The devices were distributed nationwide in the United States as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada. The FlowCoupler system is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively.
Healthcare providers and consumers should stop using the affected devices and contact Baxter Healthcare for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-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
- 118
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)
- SPI5E12-1049765 thru SPl5Hl8-1071450
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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