Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect
Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.
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 is classified as FDA Class II, and the defect involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 1,960 units of the Cardinal Health NPWT Occlusion Detection Canister 300cc. The recall involves specific model number 48-4000 and lot numbers 201829015, 201923314, 201923316, 201923319, 20192347, 201923414, and 201923410. These prescription-only devices are intended for use on patients with chronic, acute, traumatic, sub-acute, and dehisced wounds, partial-thickness burns, ulcers, flaps, and grafts in acute, extended, and home care settings.
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 or function of the negative pressure wound therapy system.
The affected units were distributed worldwide, including nationwide in the United States and in Canada. Patients and healthcare providers should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or supplier according to their instructions.
The recalled product
- Product
- Cardinal Health NPWT Occlusion Detection Canister 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
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Wound Care
- Affected units
- 1,960
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 (8)
- Model Numbers: 48-4000
- Lot numbers:201829015
- 201923314
- 201923316
- 201923319
- 20192347
- 201923414
- 201923410.
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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