FDAFDA · Food and drugs·Recall number Z-0104-2016
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Published October 14, 2015 · Recall initiated: April 22, 2015
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
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Resource Optimization & Innovation Llc
- Distributor
- Distribution was made to LA, MS, and TX.
- Lot
- Lot numbers 24298 and 24572.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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