Centurion Medical Recalls Wound Closure Tray - Facial Devices
Centurion Medical Products Corporation is recalling Wound Closure Tray - Facial devices due to a Class II FDA recall.
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, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling Wound Closure Tray - Facial devices. The recall is classified as Class II by the U.S. Food and Drug Administration.
The source text describes the product as a convenience kit containing components to assist practitioners with IV placement and securement. The recall number is Z-1098-2018.
The specific reason for the recall and instructions for consumers are not detailed in the provided source text.
The recalled product
- Product
- WOUND CLOSURE TRAY - FACIAL
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Wound Closure
- 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)
- SUT8260A Lot codes: 2016070490 2016080590 2016112990 2017090690
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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