Customed Universal Drainage Tray Recalled Due to Compromised Sterility
Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, and the source text explicitly states the hazard may result in patient infection.
Plain-English summary
Customed, Inc. is recalling 8,000 units of the Universal Drainage Tray, Catalog number 900-032. This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because the products have 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 units were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 111123439, 111123477, 112030810, 112041388, 112051661, 112072578, 140211712, and 140513053. Medical facilities should stop using these trays and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 8,000
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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