Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
FDA Recall Z-0673-2007 · Posted 2007-03-29
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Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2007-01-19
Date Terminated2007-05-11
Product Quantity192 units
Reason for Recall
Pouches were not sealed prior to sterilization.
Firm Action
Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.
Root Cause
Other
Distribution Pattern
Nationwide.
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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