Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,920 Foley catheter trays distributed in Puerto Rico due to inadequate sterilization process validation 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 sterile medical device with inadequate sterilization validation, creating a risk of infection or harm, but no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 2,920 units of the Foley Catheter Tray, Catalog Number 9001127. The affected product is a 16 FR-5CC-2WAY silicone-coated Foley catheter used by medical staff for surgical procedures and patient care, including 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 were distributed only in Puerto Rico.
No specific illnesses or injuries have been reported in the source text. Medical facilities and consumers who have this product should stop using it and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY 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
- 2,920
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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