Z-1444-2013Class II

I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each...

Name: Z-1444-2013 I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each...
Creator: I-Flow LLC
Published: 2012-06-01
License: https://open.fda.gov/license/

Halyard Health / initiated 2012-06-01 / Terminated / root cause: packaging

FDA source

I-Flow LLC began a recall of 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... on 2012-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1444-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Posted: 2013-06-03
Terminated: 2013-06-25
Recalling firm: Halyard Health
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.
Product code: BSO Catheter, Conduction, Anesthetic
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.
Root cause tag: packaging
FDA root cause: Use error
Action: IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the catheter prior to inserting it into the Stingray connector will help with connecting the catheter to the Stingray connector. Customers are instructed that there is no action required for the I Flow ON Q Pain Relief System and ON Q T Bloc. The recall letter is only to provide further instructions on successful set up of the SPIROL catheter with the Stingray Connector included in the ON-Q T-bloc trays. Customers with any questions are instructed to call IFlow Customer service at (800) 448-3569 or IFlow 24 hr Tech support at (800) 444-2728. On June 1, 2012, an I-Flow sales representative removed the catheters and connectors from the one consignee/customers. For questions regarding this recall call 949-206-2700.
Quantity in commerce: 450 units
Distribution: Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Product codes and lots: Lot # AW207202O

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1444-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1444-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-03
Z-1445-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-03

Product code BSO

K904440Class IILocal Plexus Block Anesthesia Catheter KitsPreferred Medical Products / cleared 1991-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)