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 of 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 sterile medical device with inadequate sterilization validation, posing a risk of infection or harm, but no injuries or illnesses have been reported in the source text.
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 procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15215, SL15222, SL15246, and SL15252, with expiration dates of July 31, 2016, and August 31, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these specific lots and contact the manufacturer for further instructions.
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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