Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2543-2020·Announced 2020-07-15

Cardinal Health NPWT Canisters Recalled for Oversized O-Ring Defect

Cardinal Health is recalling 3,000 NPWT Canisters with Gel 300cc because they may contain an oversized O-ring that cannot be installed.

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. The hazard involves a mechanical defect (oversized O-ring) that prevents installation, which is a functional issue rather than a direct biological or chemical hazard, fitting the Moderate category for low-risk contamination or functional defects without reported injury.

Plain-English summary

Cardinal Health 200, LLC is recalling 3,000 units of the Cardinal Health NPWT Canister with Gel 300cc. The affected units are prescription-only medical devices intended for use on patients with chronic, acute, traumatic, sub-acute, and dehisced wounds, partial-thickness burns, ulcers, flaps, and grafts. The recall covers specific model numbers and lot numbers distributed in the United States and Canada.

The recall was initiated because the canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. This defect may prevent the proper assembly of the negative pressure wound therapy system.

Healthcare providers and patients using these specific lot numbers should stop using the affected canisters and contact Cardinal Health for further instructions or replacement.

The recalled product

Product: Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Wound Care
Hazard: mechanical-defect
installation-failure
Affected units: 3,000

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 (13)

Model Numbers: 47-4000
Lot numbers:201921913
201921915
201921919
201922009
201922017
201922019
201922021
201922118
201922419
201922120
201922121
201922421

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cardinal Health 200, LLC 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 · Cardinal Health 200, LLC

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