The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0976-2020·Announced 2020-02-12

Cook Inc. Recalls Sof-Flex Ureteral Stent Sets Due to Loading Error

Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could result in significant injury by introducing a stiff tip into a patient, meeting the criteria for a Severe rating.

Plain-English summary

Cook Inc. is recalling 13,388 units of the Sof-Flex Multi-Length Ureteral Stent Set. The affected products include Global Product Numbers G14773, G15000, G14867, G14951, and G17852. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is due to a potential defect where the wire guide may be incorrectly loaded into the wire guide holder. This error could lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip. The 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 the affected stent sets and contact Cook Inc. for further instructions. Consumers who have purchased these medical devices should consult their healthcare provider regarding the recall and potential risks associated with the stiff tip introduction.

The recalled product

Product
Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
Manufacturer
Cook Inc.
Category
Medical Device — Urological Stents
Hazard
Affected units
13,388

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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