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Terminated

Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090

FDA Recall Z-0922-05 · Posted 2005-06-22

Recalling FirmManan Medical Products, Inc.
Recall StatusTerminated
Product CodeKXK
Date Initiated2005-05-03
Date Terminated2005-08-29
Product Quantity22,900 units

Reason for Recall

The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.

Firm Action

Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.

Root Cause

Other

Distribution Pattern

Florida and Georgia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902622MANAN PROSTATE SEEDING NEEDLEManan Medical Products, Inc. · 1990-08-10

Official Source

View FDA Recall →

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

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