FDAFDA · Food and drugs·Recall number Z-0283-2015
Premium Cesarean Pack, Catalog number 900-1294 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 140412594 140513078 140513477 140714172 140814642 140814732
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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