Customed Urethral Catheter Trays Recalled for Compromised Sterility
Customed, Inc. is recalling Urethral Catheter Trays due to compromised sterility and manufacturing deficiencies that may increase the risk of 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 indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The source explicitly states the risk of patient infection due to compromised sterility.
Plain-English summary
Customed, Inc. is recalling 50,950 units of Urethral Catheter Trays, Catalog number 900-278. 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 recall includes specific lot numbers ranging from 111113096 to 140915160. Medical facilities and consumers should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Uretheral Catheter Tray, Catalog number 900-278. 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 Trays
- Hazard
- Affected units
- 50,950
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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