Device product
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Z-0649-2013
Product summary
- Event
- Event 63896
- Status
- Terminated
- Classification
- Class II
- Quantity
- S112462=995 units & S111480 1430 units
- Official record key
device-enforcement:Z-0649-2013
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-12202 Lot No: S112462, S111480
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.