The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1238-2016·Announced 2016-03-30

Cook Medical Recalls Ureteral Balloon Catheters Due to Labeling Mix-Up

Cook Medical is voluntarily recalling specific lots of Ascend AQ Ureteral Dilation Balloon Catheter Sets and Ultraxx Nephrostomy Balloon Sets due to a labeling error where packages may contain the wrong product.

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 error (mix-up) rather than a manufacturing defect or contamination. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.

Plain-English summary

Cook Medical is voluntarily recalling specific lots of the Ascend AQ Ureteral Dilation Balloon Catheter Set and the Ultraxx Nephrostomy Balloon Set. The recall is being conducted because of a labeling mix-up where packages labeled as one product were found to actually contain the other.

The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation. The affected product is identified by Catalog # AUBS-6-4, GPN# G32840, Lot# 5083854, and an expiration date of 06/01/2017. The recall involves 20 units distributed worldwide, including in the US states of Georgia, Idaho, Louisiana, Oregon, South Carolina, and Texas, as well as internationally to China.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. They should contact Cook Medical for instructions on how to return the recalled items.

The recalled product

Product
Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral…
Manufacturer
Cook Inc.
Category
Medical Device — Urological Devices
Hazard
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 # AUBS-6-4 GPN# G32840 Lot# 5083854 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 →

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