Customed Urology PK 5/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits in Puerto Rico 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 risk-of-harm product (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits. 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 141015743 (exp. 11/30/15), 141216418 (exp. 12/31/15), 150317635 (exp. 3/31/16), and 150318109 (exp. 3/31/16), all under code 9001738.
The products were distributed only in Puerto Rico. The source text does not specify any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- UROLOGY PK 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
- Category
- Medical Device — Surgical Kits
- Affected units
- 10
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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