Customed Cardiovascular Case Carts 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 constitutes a risk of significant injury. This aligns with the rubric criterion for 'Severe' (4) involving significant injury reports or risks, and the agency classification is Class I.
Plain-English summary
Customed, Inc. is recalling 48 units of the Cirugia Cardiovascular Case Cart, Catalog number 900-1500. These carts are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are associated with lot numbers 140412871, 140613717, 140614025, 140714326, 140814867, and 140814991.
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. Medical facilities that have received these products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cirugia Cardiovascular Case Cart, Catalog number 900-1500. 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
- Hazard
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 140412871 140613717 140614025 140714326 140814867 140814991
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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