Z-0649-2013 Class II Terminated
FDA device recall Z-0649-2013 was initiated by California Medical Laboratories Inc on November 2, 2012 and is designated Class II. 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 a… The recall status is terminated (terminated March 4, 2013). Affected quantity: S112462=995 units & S111480 1430 units.
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
- S112462=995 units & S111480 1430 units
Product Description
Sterile Rigid Tip Suction Wand 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-12202 Lot No: S112462, S111480