Customed Total Hysterectomy Kits Recalled for Sterility Compromise
Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that 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 (medical device) where the hazard is potential patient infection due to compromised sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling six units of Total Hysterectomy kits, catalog #900-2415, lot number 140412654. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of significant 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 the exact number of affected patients or report any specific illnesses or injuries.
The recalled product
- Product
- Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 6
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 140412654
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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