Customed Wound Management Tray Recalled Due to Compromised Sterility
Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies 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 (infection) where the source text does not explicitly report that injuries or illnesses have occurred, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling 13,680 units of the Wound Management Tray III (Catalog number 900-540). These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated 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 112020506, 112030882, 112062454, 112093946, 112114888, 113047160, 113068174, 113109854, 131210826, 140211849, 140412693, 140613605, and 140915161.
The recalled product
- Product
- Wound Management Tray Ill, Catalog number 900-540. 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
- 13,680
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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