Customed Wound Closure Tray I Recalled Due to Compromised Sterility
Customed, Inc. is recalling Wound Closure Tray I units 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 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 Wound Closure Tray I, Catalog number 900-063, because of compromised sterility. The recall is not limited to potentially damaged packaging; rather, serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions have been identified. These conditions increase the risk of contamination, which may result in patient infection.
The affected product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall covers 66,250 units distributed to Florida, New York, and Puerto Rico. Specific lot numbers are listed in the official recall record.
Medical facilities and consumers should stop using the affected Wound Closure Tray I units immediately. Users should contact Customed, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 66,250
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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