Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1686-2020·Announced 2020-04-15

Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

Baxter Healthcare is recalling 209 GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

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 is a labeling mismatch which is a minor labeling error without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling 209 units of GEM Microvascular Anastomotic Coupler Devices. The recall is due to a potential labeling error where the Coupler size labeling on the outer tray may not match the Coupler size labeling on the inner tray. These devices are intended for use in the anastomosis of veins and arteries in microsurgical procedures within the peripheral vascular system.

The affected product is identified by Product Code 5111-00200-060, GEM2752, and Lots SP19J08-1401476 and SP19J09-1401614. The devices were distributed worldwide, including nationwide in the United States and in various international countries such as Saudi Arabia, Italy, and Canada.

Healthcare providers and consumers should check their inventory for the specific lot numbers and product codes listed. If the devices are found, they should be removed from use and returned to Baxter Healthcare Corporation or the original supplier in accordance with the recall instructions.

The recalled product

Product: GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
Affected units: 209

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 (3)

Product Code 5111-00200-060
GEM2752
Lots SP19J08-1401476 and SP19J09-1401614

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation 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 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · mis labeling