The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0974-2020·Announced 2020-02-12

Cook Inc. Recalls Kwart Retro-Inject Ureteral Stent Sets

Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

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 3/5 (High).

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 could lead to patient injury (stiff tip introduction), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 13,388 units of the Kwart Retro-Inject Ureteral Stent Set (Global Product Nos. G15016, G14836, G14885, G14887, G17151). The recall is due to a potential defect where the wire guide may be incorrectly loaded into the wire guide holder.

If the wire guide is loaded incorrectly, the stiff tip of the wire guide may be introduced into the patient instead of the flexible tip. This defect poses a risk of injury to the patient during the procedure.

The affected products were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, Germany, India, Japan, and the United Kingdom. Healthcare providers and facilities should stop using these devices and contact Cook Inc. for further instructions on the recall.

The recalled product

Product
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Manufacturer
Cook Inc.
Category
Medical Device — Urological Devices
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)

  • 8011027 8183322 8037660 8030233 8018054 7994816

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 →

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