FDAFDA · Food and drugs·Recall number Z-0250-2015
Skin Staple Removal, Catalog number 900-782. 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: 111112954 111112965 111123297 111123444 112010204 112020511 112030694 112051651 112052014 112083064 112093637 112104287 112114538 112124884 113025834 113026068 113036743 113047031 113057506 113067936 113067964 140111127 140312184 140513161 140613781 140814822 1130688891
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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