Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the source text states the defect 'may result in patient infection' but does not report any actual illnesses or injuries, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling Surgeon Reinforced Gown XL, Catalog number 900-521, due to compromised sterility. The recall includes 89,284 units distributed to Florida, New York, and Puerto Rico. 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 because of serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These issues increase the risk of contamination, which is not limited to potentially damaged packaging, and may result in patient infection.
Medical facilities and consumers should stop using the affected gowns immediately. The specific lot numbers subject to the recall are: 111103264, 112010182, 112020504, 112030803, 112041055, 112051992, 112062557, 112062558, 112072803, 112093630, 112104254, 112104360, 112114532, 112114896, 112125100, 113026195, 113036464, 113036803, 113057608, 113057848, 113068173, 113088872, 113089076, 113109851, 131210264, 131210653, 140111125, 140211539, 140312172, 140312383, 140513369, 140714294, 140714515, 140814956, and 140915480.
The recalled product
- Product
- Surgeon Reinforced Gown XL, Catalog number 900-521. 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 Gowns
- Hazard
- Affected units
- 89,284
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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