The Recall Desk
HighFDA (Devices)·Z-0968-2020·Announced 2020-02-12

Cook Inc. Recalls Percutaneous Malecot Nephrostomy Sets Due to Wire Guide Loading Error

Cook Inc. is recalling 13,388 Percutaneous Malecot Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients 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 (introduction of 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 where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 13,388 units of the Percutaneous Malecot Nephrostomy Set, identified by Global Product Numbers G16714, G19107, and G19108. 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, Germany, Japan, and the United Kingdom. The specific lot codes associated with this recall are NS8070854, 8078209, and 8116743.

Healthcare providers and facilities should stop using the affected sets and contact Cook Inc. for instructions on how to return or dispose of the products. Patients who have had these sets used should consult their healthcare provider if they have concerns regarding the procedure.

The recalled product

Product
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Manufacturer
Cook Inc.
Category
Medical Device — Nephrostomy Set
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)

  • NS8070854 8078209 8116743

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

Same manufacturer · Cook Inc.

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Same hazard · improper device use

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