Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because the company could not validate the sterilization process or 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 is classified as FDA Class II. The hazard involves a sterile medical device where the sterilization process was not adequately validated, creating a risk of infection or harm, but the source text does not report any specific 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 540 units of sterile Mayo stand covers (Catalog Number 9001771). These products are used by medical staff to perform 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 the products released for distribution as sterile.
The affected lots are SL15215, SL15222, SL15246, and SL15252. The products were distributed only in Puerto Rico. The source text does not specify the number of affected patients or report any illnesses or injuries associated with the use of these devices.
Medical facilities and consumers who possess these specific lots should stop using the products and contact the manufacturer or their supplier for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Catalog Number: 9001771 MAYO STAND COVER STERILE 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
- 540
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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