The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0969-2020·Announced 2020-02-12

Cook Percutaneous Pigtail Nephrostomy Set Recalled for Wire Guide Loading Error

Cook Inc. is recalling Percutaneous Pigtail Nephrostomy 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 (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 Percutaneous Pigtail Nephrostomy Sets (Global Product Nos. G14094, G14095, G14899, G14329). 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 incorrectly loaded, 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 to the United States and internationally to numerous countries, including Australia, Canada, Germany, Japan, and the United Kingdom. Healthcare providers and facilities that have received these products should stop using them and contact Cook Inc. for further instructions on the recall.

The recalled product

Product
Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
Manufacturer
Cook Inc.
Category
Medical Device — Nephrostomy Sets
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)

  • 8112670 8113259 8113260 8113261 NS8070847 8076035

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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