Device product
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.
Z-0650-2013
Product summary
- Event
- Event 63896
- Status
- Terminated
- Classification
- Class II
- Quantity
- S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
- Official record key
device-enforcement:Z-0650-2013
Official wording
Reason: 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.
Code information: Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
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.
Derived failure modes
-
Unknown
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.