I-Flow LLC: 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.

Agency Publication Date: June 3, 2013

Affected Products

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.

Lot # AW207202O

Lot Numbers:

AW207202O

Product: 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.

Lot # AW207202U

Lot Numbers:

AW207202U

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64826

Status: Resolved

Manufacturer: I-Flow LLC

Manufactured In: United States

Units Affected: 2 products (450 units; 75 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot # AW207202O

Lot Numbers:

AW207202O

Lot # AW207202U

Lot Numbers:

AW207202U