Centurion Medical Products Recalls Wound Care Kits
Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.
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 is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically rated as High (3), representing a risk of temporary or medically reversible health consequences.
Plain-English summary
Centurion Medical Products Corporation is recalling Wound Care Kits. The product is a convenience kit containing components to assist practitioners with IV placement and securement. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall number is Z-1097-2018. The specific lot code identified in the recall is 2016072190. The product was distributed nationally.
The source text does not specify the exact reason for the recall, the number of units affected, or any reported injuries or illnesses. Consumers and healthcare providers should check their inventory for the specific lot code and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- WOUND CARE KIT
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
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)
- SUT13705 Lot codes: 2016072190
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Centurion Medical Products Corporation 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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