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.
What this means for you
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 Car
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Wound Care
- 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.
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