Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect
Baxter Healthcare is recalling 707 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a packaging issue (booklet puncturing the lid) with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.
Plain-English summary
Baxter Healthcare Corp. is recalling 707 units of GEM FlowCoupler devices, reference number GEM2754-FC. The devices are single-use, implantable medical devices 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 devices were distributed nationwide in the United States, as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada. The specific lot codes affected are SP15H05-1067841 through SP15L02-1102423.
Healthcare providers and consumers should stop using the affected devices and contact Baxter Healthcare Corp. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-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
- 707
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)
- SP15H05-1067841 thru SP15L02-1102423
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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