Customed Cardiovascular Case Cart Recalled for Compromised Sterility
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts 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 aligns with the rubric criterion for 'significant injury' or risk of serious harm, warranting a score of 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 48 units of the Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. These carts 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. The source text indicates that serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination. This risk 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 140412872, 1405133354, 140513354, 140613716, 140613945, 140814327, and 140914990. Medical facilities should stop using these units and contact the recalling firm for instructions.
The recalled product
- Product
- Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Carts
- Affected units
- 48
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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