Customed Arthroscopy PK L/F 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
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 is classified as FDA Class II. The hazard involves potential failure of sterilization and package integrity for sterile medical devices, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS. These medical devices are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products that were released for distribution as sterile. The affected products were distributed only in Puerto Rico.
The recall involves specific lots with expiration dates ranging from October 31, 2015, to June 30, 2016. Users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
- Manufacturer
- Customed, Inc
- Affected units
- 115
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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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