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Terminated

PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

FDA Recall Z-0974-05 · Posted 2005-07-07

Recalling FirmTheragenics Corporation
Recall StatusTerminated
Product CodeKXK
Date Initiated2005-05-16
Date Terminated2005-10-05
Product Quantity13 loads

Reason for Recall

The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.

Firm Action

Consignees were contacted on 5/16/2005 via telephone and email.

Root Cause

Other

Distribution Pattern

OH, VA

Official Source

View FDA Recall →

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

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