Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 160 units of Foley Catheter 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 is classified as FDA Class II. The hazard involves potential sterility failure in a medical device used for invasive procedures, 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 160 units of Foley Catheter Kits (16FR with Foley S Sensor) in Puerto Rico. 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 product is used by medical staff for surgical procedures and patient care, including wound healing, suture removals, and wound irrigation. The specific lots involved are 141115955 (exp. 12/31/15), 150217440 (exp. 2/28/16), and 150619462 (exp. 6/30/16), all under code 900150PKC.
Medical facilities and consumers in Puerto Rico should stop using these specific lots and contact the manufacturer or their supplier for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/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 — Catheters
- Affected units
- 160
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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