Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1628-2016·Announced 2016-05-18

Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

Baxter Healthcare is recalling 630 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, and the hazard involves a packaging defect that may compromise sterility. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving potential contamination or labeling/packaging issues.

Plain-English summary

Baxter Healthcare Corp. is recalling 630 units of GEM FlowCoupler devices, reference number GEM2753-FC. These are single-use, implantable devices intended for end-to-end anastomosis of veins and arteries in microsurgical and vascular reconstructive procedures. The devices are sterile and distributed nationwide as well as in Germany, Sweden, the Netherlands, Israel, Denmark, the United Kingdom, and Canada.

The recall is due to a packaging defect where the instructions for use booklet may puncture the outer Tyvek lid. This defect could potentially compromise the sterility of the device. The affected lot codes range from SP15H05-1067842 through SP15KI9-1099303.

Healthcare providers and facilities should stop using the affected devices and contact Baxter Healthcare for further instructions. Consumers should not use these devices if they have them in their possession.

The recalled product

Product: GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-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…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Surgical Implants
Hazard: packaging-defect
sterility-compromise
Affected units: 630

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)

SP15H05-1067842 thru SP15KI9-1099303

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.

See all 5 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · packaging defect