Customed Skin Staple Removal Recalled Due to Compromised Sterility
Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in 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 (infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling 20,960 units of Skin Staple Removal devices, Catalog number 900-782. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination, which may result in patient infection.
The affected products were distributed to Florida, New York, and Puerto Rico. The specific lot numbers involved are: 111112954, 111112965, 111123297, 111123444, 112010204, 112020511, 112030694, 112051651, 112052014, 112083064, 112093637, 112104287, 112114538, 112124884, 113025834, 113026068, 113036743, 113047031, 113057506, 113067936, 113067964, 140111127, 140312184, 140513161, 140613781, 140814822, and 1130688891. Healthcare facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 20,960
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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