Customed Mayo Stand Covers Recalled for Sterilization Process Defects
Customed, Inc. is recalling 540 units of Mayo Stand Covers due to inadequate validation of sterilization processes and package integrity.
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 involves a medical device with a defect in sterilization validation, 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 without reported injury.
Plain-English summary
Customed, Inc. is recalling 540 units of Mayo Stand Covers with CSR Wrap (Code 9001771, Lot 150116963, exp. 1/31/16). 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 because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. This defect means the products may not be sterile as intended.
The affected units were distributed only in Puerto Rico. Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- MAYO STAND COVER W/CSR WRAP 30/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
- 540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Code:9001771 Lots: 150116963 exp. 1/31/16
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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