Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1237-2016·Announced 2016-03-30

Cook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up

Cook Medical is voluntarily recalling specific lots of Ultraxx Nephrostomy Balloon Sets and Ascend AQ Ureteral Dilation Balloon Catheter Sets because of a labeling mix-up.

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 involves a labeling mix-up, which aligns with the rubric criteria for moderate severity involving minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Cook Medical is voluntarily recalling specific lots of the Ultraxx Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set. The recall is being conducted because of a labeling mix-up.

Cook Medical has received reports that packages labeled as the Ultraxx Nephrostomy Balloon Set actually contained the Ascend AQ Ureteral Dilation Balloon Catheter Set, and vice versa. The Ultraxx Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

The affected products were distributed worldwide, including in the United States (Georgia, Idaho, Louisiana, Oregon, South Carolina, and Texas) and internationally to China. The specific lot number is 5082013, with an expiration date of 06/01/2017. Healthcare providers and consumers should check their inventory for these specific lots and stop using the products if they match the affected description.

The recalled product

Product: UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and…
Manufacturer: Cook Inc.
Category: Medical Device — Catheters
Hazard: mis-labeling
Affected units: 20

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)

Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Cook Inc. 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 2 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · mis labeling