Customed Impervious Gowns Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 240 impervious gowns due to compromised sterility and manufacturing deficiencies that may cause 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 source text explicitly states that the deficiencies 'may result in patient infection,' which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Customed, Inc. is recalling 240 units of Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. These gowns are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified 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 are 140513356, 140613743, 140714277, and 140814798. Medical facilities and consumers should stop using these gowns and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. 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
- 240
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 140513356 140613743 140714277 140814798
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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