FDAFDA · Food and drugs·Recall number Z-0251-2015
Wound Management Tray, Catalog number 900-1154. 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: 111112986 111123441 112010278 112041183 112051733 112062333 112093745 112104134 113026216 113047151 113068038 113078678 131110157 140111110 140312050 140513069 140814630 1130154790
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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