FDAFDA · Food and drugs·Recall number Z-0650-2013
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Published January 16, 2013 · Recall initiated: November 2, 2012
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
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- California Medical Laboratories Inc
- Distributor
- Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
- Lot
- Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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