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U.S. Department of Health and Human Services

Class 2 Device Recall Prostate Seeding Needle, Applicator Technique

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  Class 2 Device Recall Prostate Seeding Needle, Applicator Technique see related information
Date Initiated by Firm August 12, 2011
Date Posted October 12, 2011
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-0040-2012
Recall Event ID 59712
Product Classification Manual Radionuclide Applicator System - Product Code IWJ
Product Prostrate Seeding Applicator Needle. Product code PSS1820AT
Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs.
Worldwide Medical Technologies, LLC

Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate
Code Information Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07
Recalling Firm/
Manufacturer
Worldwide Medical Technologies, LLC
115 Hurley Rd Ste 3b
Oxford CT 06478-1047
For Additional Information Contact
203-262-4190 Ext. 105
Manufacturer Reason
for Recall
Length of the cannula hub is longer and may not permit a fit with the Applicator
FDA Determined
Cause 2
Nonconforming Material/Component
Action BrachySciences, a division of Biocompatibles, Inc., sent out "Urgent Recall Device Recall" letters Dated August 12, 2011 to all affected customers. The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm. For questions on this recall contact the firm at (203) 262-0571, extension 105.
Quantity in Commerce 1872 units
Distribution Worldwide Distribution: Nationwide distribution including the states of AR, CO, DE. FL, KY, MD, MI, MN, NY, TX, and VA; and the countries of Belgium, and Germany.
Total Product Life Cycle TPLC 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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