Customed Tracheotomy Care Kits Recalled for Sterility Compromise
Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the recall is due to compromised sterility which 'may result in patient infection.' Under the severity rubric, a risk of harm where injury has not yet been reported but the hazard is significant (infection from non-sterile medical devices) aligns with a score of 4 (Severe), as it involves a significant health risk beyond a theoretical or minor labeling issue.
Plain-English summary
Customed, Inc. is recalling 78,600 units of Tracheotomy Care Kits, Catalog number 900-110. These kits are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to compromised sterility, which is not limited to potentially damaged packaging.
The recall was initiated because of serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions. These factors increase the risk of contamination, which may result in patient infection. The affected products were distributed to Florida, New York, and Puerto Rico.
Medical facilities and consumers should stop using the affected Tracheotomy Care Kits immediately. The specific lot numbers affected are listed in the official recall documentation. Users should contact the manufacturer or their medical supply provider for further instructions on disposal or replacement.
The recalled product
- Product
- Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 78,600
Distribution
Part of a larger recall action
This product is one of 179 recalled by Customed, Inc 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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