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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXIGUIDE NEEDLE, SERIES15

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 Class 2 Device Recall FLEXIGUIDE NEEDLE, SERIES15see related information
Date Initiated by FirmNovember 15, 2007
Date PostedOctober 22, 2008
Recall Status1 Terminated 3 on December 09, 2008
Recall NumberZ-0170-2009
Recall Event ID 49128
Product Classification Needle - Product Code IWJ
ProductAlpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE, SERIES-15, 25 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-010. 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.
Code Information Lots: F02497, and F02574
FEI Number 2022694
Recalling Firm/
Manufacturer		 Alpha Omega Services Inc
9156 Rose Street
Bellflower CA 90706-6420
For Additional Information Contact
562-804-0604
Manufacturer 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 2		Nonconforming Material/Component
ActionNotification 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 Commerce40 pkgs (10 each pkg)
DistributionNV, AZ, CA, MI, UT, MO, CO, and OH
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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