FDA Device Recall Z-0040-2012: Worldwide Medical Technologies, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0040-2012.

Recall Res Number

Z-0040-2012

Recalling Firm / Manufacturer

Worldwide Medical Technologies, LLC

FEI Number

3000206637

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-08-12

Date Posted

2011-10-12

Date Terminated

2012-09-19

Product Code

IWJ

Event Number

59712

Product Quantity

1872 units

Product Description 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

Reason for Recall Length of the cannula hub is longer and may not permit a fit with the Applicator

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07

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Medical Device Recall: Z-0040-2012

Recall Parameters & Description

Related Establishments / Registrations

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