Z-1445-2013 Class II Terminated
FDA device recall Z-1445-2013 was initiated by I-Flow LLC on June 1, 2012 and is designated Class II. Reason for recall: I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned. The recall status is terminated (terminated June 25, 2013). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- June 1, 2012
- Termination Date
- June 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Reason for Recall
I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
Distribution Pattern
Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Code Information
Lot # AW207202U