Customed Premium Arthroscopy PK Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK 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 involves a medical device with inadequate sterilization validation, which poses a risk of harm (infection) even though no injuries are reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK. These products are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are 141015770 (exp. 11/30/15), 141115977 (exp. 11/30/15), and 150116759 (exp. 2/28/16), all under code 9001298.
The products were distributed only in Puerto Rico. The source text does not specify further consumer actions or report any illnesses or injuries.
The recalled product
- Product
- PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Affected units
- 55
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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