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Terminated

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

FDA Recall Z-1717-2009 · Posted None

Recalling FirmSource Production & Equipment Inc
Recall StatusTerminated
Product CodeKXK
Date Initiated2008-03-03
Date Terminated2009-08-19
Product Quantity3 units

Reason for Recall

Radioactive source broke during use.

Firm Action

Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.

Root Cause

Other

Distribution Pattern

Nationwide Distribution -- GA, NV and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052947SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCESource Production & Equipment Co., Inc. · 2006-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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