Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Laparoscopy Gyn Pack Recalled by Customed, Inc Due to Significant compromised sterility, not limited to potentially damaged...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Customed, Inc directly.
Affected Products
Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Quantity: 160
Why Was This Recalled?
Significant compromised sterility, 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.
Where Was This Sold?
US Distribution to Florida, New York and Puerto Rico..
About Customed, Inc
Customed, Inc has 682 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report