Customed Medical Leggings Recalled Due to Compromised Sterility
Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies 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 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 3,540 units of Leggings W/7'' Cuff, Catalog number 900-1574. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to compromised sterility, which is not limited to potentially damaged packaging.
The recall is being conducted because of serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions. These issues 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 in this recall are 112010064, 112062429, 112072429, 113015552, 113078579, 140211537, 140613802, 140714188, and 140814663. Medical facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products immediately.
The recalled product
- Product
- Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 3,540
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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