Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0106-2021·Announced 2020-10-21

Cook Inc. Recalls Pediatric Nephrostomy Stent Sets Due to Labeling Update

Cook Inc. is recalling 380 Pediatric Nephrostomy Stent Sets because the indwell time is decreasing from 4 months to 4 weeks. The Instructions for Use are being updated to reflect this change.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/documentation update regarding indwell time without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cook Inc. is recalling 380 units of the Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The recall is due to a change in the recommended indwell time for the device, which is decreasing from 4 months to 4 weeks.

The current Instructions for Use (IFU) are in the process of being updated to reflect this new timeframe. The updated IFU will be provided with orders placed following the implementation of the change. The affected products were distributed worldwide and nationwide in the US.

No specific consumer action is detailed in the source text beyond the manufacturer's process of updating documentation. The recall is classified as Class II by the FDA.

The recalled product

Product: Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way…
Manufacturer: Cook Inc.
Category: Medical Device — Nephrostomy Stent
Hazard: mis-labeling
Affected units: 380

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)

All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · mis labeling