Customed Gown Surg Fully Impervious Large Recalled for Compromised Sterility
Customed, Inc. is recalling 170 units of Gown Surg Fully Impervious Large due to compromised sterility and manufacturing deficiencies that may result in patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the compromised sterility 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects that pose a serious health threat.
Plain-English summary
Customed, Inc. is recalling 170 units of Gown Surg Fully Impervious Large, Catalog number 900-2564. These gowns are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot number is 112104267.
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 product was distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Gown Surg Fully Impervious Large, Catalog number 900-2564. 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
- 170
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: 112104267
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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