Z-1717-2009

M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source

Name: Z-1717-2009 M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source
Creator: Source Production & Equipment Inc
Published: 2008-03-03
License: https://open.fda.gov/license/

Source Production and Equipment Co., Inc. / initiated 2008-03-03 / Terminated

FDA source

Source Production & Equipment Inc began a recall of M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source on 2008-03-03. The reason FDA records is "Radioactive source broke during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1717-2009
Status: Terminated
Initiated: 2008-03-03
Posted: 2015-06-25
Terminated: 2009-08-19
Recalling firm: Source Production and Equipment Co., Inc.
Product: M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
Product code: KXK Source, Brachytherapy, Radionuclide
Reason for recall: Radioactive source broke during use.
FDA root cause: Other
Action: Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.
Quantity in commerce: 3 units
Distribution: Nationwide Distribution -- GA, NV and NY.
Product codes and lots: OSI A011, OSI A010, and OSI A015.

Product code KXK

K052947Class IISource Production & Equipment Co, Inc., Model M-19 Ir-192 Brachytherapy SourceSource Production & Equipment Co., Inc. / cleared 2006-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)