Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk of harm due to potential sterility failure, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 5,500 units of Urethral Catheter Tray Customed 50/CS. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as issues with package integrity for products that were released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lots with expiration dates ranging from January 31, 2016, to June 30, 2016. These trays are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
Healthcare facilities and consumers who have these products should stop using them and contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- URETHRAL CATHETER TRAY CUSTOMED 50/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
- 5,500
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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