Customed Recalls O.R. Towels Due to Sterilization Process Validation Issues
Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
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, and the hazard involves a risk-of-harm product (sterile medical device) where the lack of sterilization validation presents a potential risk, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 300 cases of O.R. Towels (25/CS) that were distributed exclusively in Puerto Rico. These towels are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation.
The recall was initiated because the company did not adequately validate or qualify the sterilization processes and package integrity for these products, which were released for distribution as sterile. The affected lots include 150116616, 150116615, 150116614, 150116986, 141216355, 150318007, 150318008, 150318009, 150519013, and 150619291, with expiration dates ranging from January 31, 2016, to June 30, 2016.
Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact Customed, Inc. for instructions on how to return or dispose of them.
The recalled product
- Product
- O.R. TOWELS 25/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
- 300
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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