Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1682-2013·Announced 2013-07-17

Baxter Recalls Four Lead TUR Irrigation Sets Due to Packaging Pinholes

Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.

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 potential compromise of the sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Baxter Healthcare Corp. is recalling 356,728 units of Four Lead TUR irrigation Sets (Product Code 2C4013) distributed nationwide in the United States. These medical devices are intended for the delivery of irrigating solutions during bladder irrigation or endoscopic procedures, including cytoscopy, transurethral resection, and arthroscopic procedures.

The recall was initiated after an internal investigation discovered pinholes in the product packaging. These pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging, potentially exposing the device to contamination.

Healthcare providers and facilities should check their inventory for the specific lot codes listed in the recall notice and stop using any affected units. Consumers should contact their healthcare provider if they have questions regarding the use of these devices.

The recalled product

Product: Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Surgical Irrigation
Hazard: sterility-compromise
packaging-defect
Affected units: 356,728

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility compromise