Customed Recalls Sterile Surgical Towels Due to Sterilization Validation Issues
Customed, Inc. is recalling 125 sterile surgical towels distributed in Puerto Rico because the sterilization process and package integrity were not adequately validated.
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 where the sterilization process was not adequately validated, creating a risk of harm from potential contamination, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Customed, Inc. is recalling 125 units of Catalog Number 900629 STERILE OR CLOTH TOWEL BLUE. These products 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 due to inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. The affected lots are SL15170, SL15191-01, SL15223, and SL15225.
The products were distributed only in Puerto Rico. Medical facilities and consumers who possess these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE 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
- 125
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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