Z-0650-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2013
- Initiation Date
- November 2, 2012
- Termination Date
- March 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N