The Recall Desk
HighFDA (Devices)·Z-0967-2020·Announced 2020-02-12

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

Cook Inc. is recalling 13,388 Percutaneous Entry Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into 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 physical 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 Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649. The recall was initiated because 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 8109245 and NS8109246.

Healthcare providers and facilities should check their inventory for these specific product numbers and lot codes. If the affected products are found, they should be removed from use and returned to Cook Inc. according to the company's instructions. Patients who have already received these devices should contact their healthcare provider for guidance.

The recalled product

Product
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Manufacturer
Cook Inc.
Category
Medical Device — Nephrostomy 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)

  • 8109245 NS8109246

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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