Centurion Tracheostomy Care Kits Recalled Due to Incomplete Package Seals
Centurion Medical Products is recalling specific tracheostomy care kits because incomplete seals on the sterile packaging 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 involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (compromised sterility) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of tracheostomy care kits and trays. The affected products include the TC6282G Tracheostomy Care Tray, TC7170 Latex Free Tracheostomy Care Tray, TC7370 Tracheostomy Kit, and TC7450 Disposable Trach Tray.
The recall was initiated because incomplete seals on the sterile packaging may compromise the sterility of the medical devices. The specific lot numbers affected are 2019013190, 2018101690, 2018121790, and 2019011690.
These products were distributed nationwide and in Ghana. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products if found.
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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