I-Flow LLC: Medical Device Recall in 2013 - (Recall #: Z-1445-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 1, 2012

Date Posted: June 12, 2013

Recall Number: Z-1445-2013

Event ID: 64826

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.

Status: Terminated

Product Quantity: 75 units

Code Information:

Lot # AW207202U

Distribution Pattern:

Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated