Z-0922-05

Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded...

Name: Z-0922-05 Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded...
Creator: Manan Medical Products, Inc.
Published: 2005-05-03
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2005-05-03 / Terminated

FDA source

Manan Medical Products, Inc. began a recall of 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... on 2005-05-03. The reason FDA records is "The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0922-05
Status: Terminated
Initiated: 2005-05-03
Posted: 2005-06-22
Terminated: 2005-08-29
Recalling firm: Argon Medical Devices, Inc
Product: 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
Product code: KXK Source, Brachytherapy, Radionuclide
Reason for recall: The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
FDA root cause: Other
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.
Quantity in commerce: 22,900 units
Distribution: Florida and Georgia
Product codes and lots: Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015

Product code KXK

K902622Class IIManan Prostate Seeding NeedleManan Medical Products, Inc. / cleared 1990-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)