FDAFDA · Food and drugs·Recall number Z-0257-2015
Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Published December 10, 2014 · Recall initiated: October 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- US Distribution to Florida, New York and Puerto Rico..
- Lot
- Lot numbers: 111103390 112041455 112062288 112093634 113046894 113088762 140111121 140111176 140814743
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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