The Recall Desk
HighFDA (Devices)·Z-0965-2020·Announced 2020-02-12

Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Defect

Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm to patients by introducing a stiff tip instead of a flexible one, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Cook Inc. is recalling 13,388 units of the Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598. The recall is due to a defect where the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip.

The affected products were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The specific lot codes associated with this recall are 8023195, 8314384, 8409525, NS8040177, and 7857489.

Healthcare providers and facilities should stop using the affected catheter sets and contact Cook Inc. for instructions on returning the products. Patients who have received this device should consult their healthcare provider if they have concerns regarding the procedure.

The recalled product

Product
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Manufacturer
Cook Inc.
Category
Medical Device — Urological Catheter
Hazard
Affected units
13,388

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)

  • 8023195 8314384 8409525 NS8040177 7857489

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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 20 products in this recall →

Related recalls

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