FDAFDA · Food and drugs·Recall number Z-0246-2015
Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. 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: 111103265 111113126 112010183 112020505 112030804 112041056 112051993 112072804 112093631 112104361 112104533 112124897 113026196 113036804 113057491 113067873 113078333 113088873 113099438 113109852 131110265 131210654 140111126 140211540 140312173 140312384 140513370 140714295 140814813 140814957 140915481
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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