Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AN

FDA device recall Z-0168-2009 · posted 2008-10-22 · Terminated

Recall details

Recalling firm

Alpha Omega Services Inc

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IWJ

Quantity affected

1 pkg (100 each pkg)

Distribution

NV, AZ, CA, MI, UT, MO, CO, and OH

Date initiated

2007-11-15

Date posted

2008-10-22

Date terminated

2008-12-09

Location

Bellflower, CA