Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. by the attending physician.
FDA Recall Z-1020-2009 · Posted 2009-03-31
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Recalling FirmTheragenics Corporation
Recall StatusTerminated
Product CodeNQO
Date Initiated2008-12-08
Date Terminated2009-04-06
Product Quantity62 units
Reason for Recall
Some pouches were found to have weak seals potentially compromising sterility.
Firm Action
Consignees were notified first by telephone on December 8, 2008 and sent a follow up letter dated January 13, 2009. They were instructed to return any of the affected lots remaining in their inventory.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution -- states of VA, WI, and CO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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