Home / Recalls / I-Flow LLC / Z-1445-2013

Z-1445-2013 Class II Terminated

Recalled by I-Flow LLC — Lake Forest, CA

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

Other recalls by I-Flow LLC

  • Z-1444-2013 Class II — I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T (June 1, 2012)