Recall Z-1444-2013— I-Flow LLC

Name: FDA recall Z-1444-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-01

Class II · Terminated

Class II FDA medical device recall by I-Flow LLC, initiated 2012-06-01, terminated 2013-06-25. It names one FDA 510(k) clearance: K904440. Product: I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T 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: 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..

Recalling firm: I-Flow LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Terminated: 2013-06-25
Firm location: Lake Forest, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K904440 — LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSPreferred Medical Products·cleared 1991-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.