Recall Z-0040-2012 ยท IWJ System, Applicator, Radionuclide, Manual
Worldwide Medical Technologies, LLC
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
| Date | Oct 12, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | Length of the cannula hub is longer and may not permit a fit with the Applicator |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.