Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
What this means for you
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: This is an FDA Class II recall of a medical device used for respiratory care with a potential hazard of non-sterility. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' meriting a score of 3 (High).
Plain-English summary
Medline Industries is recalling certain Centurion PEDIATRIC/ADULT TRACHEOSTOMY T convenience kits (REF TC7895) with breather pouch lot number 323080002 due to a packaging defect.
According to the manufacturer, convenience kits packaged in the specified breather pouch lot may result in potential non-sterile product use if the vendor seal is opened or unsealed. For medical devices used in sensitive applications such as tracheostomy, non-sterility presents a potential risk.
The affected kits were distributed worldwide, including throughout the United States, Canada, and Panama. The recall involves approximately 30 units.
Affected patients, healthcare providers, and facilities should stop using affected kits and contact Medline Industries for replacement options. Healthcare providers should review their usage and distribution records for kits from the specified lot number.
The recalled product
- Product
- Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- infection-risk
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 (4)
- UDI/DI 40193489435246 (each)
- 10193489435245 (case)
- Lot Numbers: 23LBM753
- 23KBD877
Distribution
Distributed nationwide across the United States.
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