Customed Wound Management Trays Recalled for Compromised Sterility
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in 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 compromised sterility 'may result in patient infection,' which constitutes a significant injury risk. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios.
Plain-English summary
Customed, Inc. is recalling Wound Management Trays, Catalog number 900-1154, because of compromised sterility. The recall is not limited to products with potentially damaged packaging. These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions. These issues increase the risk of contamination and may result in patient infection. The recall covers 27,024 units distributed to Florida, New York, and Puerto Rico.
Affected lot numbers include 111112986, 111123441, 112010278, 112041183, 112051733, 112062333, 112093745, 112104134, 113026216, 113047151, 113068038, 113078678, 131110157, 140111110, 140312050, 140513069, 140814630, and 1130154790. Medical facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 27,024
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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