Centurion Tracheostomy Care Kits Recalled Due to Incomplete Package Seals
Centurion Medical Products is recalling specific tracheostomy care kits and trays because incomplete seals may compromise sterility.
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. The hazard involves a risk of harm (compromised sterility) in a medical device, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling specific Tracheostomy Care Kits and Trays, including the TC6282G, TC7170, TC7370, and TC7450 models. The recall is due to incomplete seals on the sterile packaging, which may compromise the sterility of the medical devices.
The affected products were distributed nationwide and in Ghana. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the defect.
Consumers and healthcare providers should stop using the affected tracheostomy kits and trays. They should contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 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.
See all 54 products in this recall →Related recalls
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