Centurion Convenience Kits Recalled Due to Defective Medtronic Light Glove
Centurion is recalling 483 convenience kits containing Medtronic light gloves with potential splits or holes that could transfer microorganisms to patients.
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 involves a risk-of-harm product (potential microorganism transfer to patient wounds) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 483 convenience kits distributed in Kansas, Indiana, Iowa, Kentucky, Montana, and South Dakota. These kits contain Medtronic/Covidien Light Gloves that are subject to a separate recall by Medtronic.
The recall was initiated because some light covers may have splits or holes. This defect may result in the transfer of microorganisms from the light handle into a patient wound.
Healthcare facilities should stop using the affected kits and contact Centurion Medical Products Corporation for instructions on how to return the product.
The recalled product
- Product
- Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 483
Distribution
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