Recall Z-0168-2009
Alpha Omega Services Inc · initiated November 15, 2007
Product
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. 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.
Codes / lots: Lot: K00136
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0168-2009
- Initiated
- November 15, 2007
- Posted by FDA
- October 22, 2008
- Terminated
- December 9, 2008
- Product code
- IWJ – System, Applicator, Radionuclide, Manual
- Quantity
- 1 pkg (100 each pkg)
- Distribution
- NV, AZ, CA, MI, UT, MO, CO, and OH
- Recalling firm
- Alpha Omega Services Inc, Bellflower, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0166-2009 | Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE:…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | 11/15/2007Terminated |
| Z-0167-2009 | Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE:…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | 11/15/2007Terminated |
| Z-0169-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | 11/15/2007Terminated |
| Z-0170-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | 11/15/2007Terminated |