Z-0169-2009

Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT...

Name: Z-0169-2009 Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT...
Creator: Alpha Omega Services Inc
Published: 2007-11-15
License: https://open.fda.gov/license/

Alpha Omega Services Inc / initiated 2007-11-15 / Terminated / root cause: manufacturing process

FDA source

Alpha Omega Services Inc began a recall of Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE... on 2007-11-15. The reason FDA records is "There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0169-2009
Status: Terminated
Initiated: 2007-11-15
Posted: 2008-10-22
Terminated: 2008-12-09
Recalling firm: Alpha Omega Services Inc
Product: Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-009. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.
Quantity in commerce: 66 pkgs (10 each pkg)
Distribution: NV, AZ, CA, MI, UT, MO, CO, and OH
Product codes and lots: Lots: F02422, F02486, and F02665

Product code IWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)