Customed Mayo Stand Covers Recalled for Compromised Sterility
Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap 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 agency classification is FDA Class I, which mandates a minimum score of 4 per the rubric. The hazard involves compromised sterility in a medical device, posing a risk of patient infection.
Plain-English summary
Customed, Inc. is recalling 10,090 units of Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. These products 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 111103390, 112041455, 112062288, 112093634, 113046894, 113088762, 140111121, 140111176, and 140814743. Medical facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 10,090
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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