Customed Wound Management Tray II Recalled for Compromised Sterility
Customed, Inc. is recalling Wound Management Tray II units 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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk…"
Plain-English summary
Customed, Inc. is recalling the Wound Management Tray II (Catalog number 900-1198) because of compromised sterility. The recall is not limited to units with potentially damaged packaging. The product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted due to serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These factors increase the risk of contamination and may result in patient infection. The recall covers 28,020 units distributed to Florida, New York, and Puerto Rico.
Affected lot numbers include 111112987, 112010275, 112030830, 112041392, 112051737, 112062338, 112072827, 112093746, 113015492, 113026217, 113047317, 113068142, 113109711, 140111111, 140312056, 140513037, 140714161, and 140915150. Medical facilities should stop using these trays and contact the recalling firm for instructions.
The recalled product
- Product
- Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 28,020
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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