Customed Surgical Gowns Recalled Due to Compromised Sterility
Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of 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 (compromised sterility leading to potential patient infection) where the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 2,670 units of Gown Surgical Fabic Reinforced Large, Catalog number 900-2569, Lot number 113036396. These gowns are 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 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 source text does not specify further consumer actions or report any illnesses or injuries.
The recalled product
- Product
- Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. 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
- 2,670
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 113036396
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.
See all 179 products in this recall →Related recalls
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