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.
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: The recall involves a risk-of-harm product (compromised sterility leading to potential infection) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 23,300 units of the Wound Management Tray Ryder Memorial, Catalog number 900-1456. These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 11123442, 111112934, 112041187, 112051647, 112051758, 112062415, 112072773, 112083390, 113026043, 113026103, 113026229, 113057384, 113068146, 113078701, 113109725, 140613855, and 140814650.
The recalled product
- Product
- Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 23,300
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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