Recall Z-0922-05 ยท KXK Source, Brachytherapy, Radionuclide
Manan Medical Products, Inc.
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. 238
| Date | Jun 22, 2005 (initiated May 3, 2005) |
| Status | Terminated |
| Reason | The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures. |
| 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 | 22,900 units |
| Distribution | Florida and Georgia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902622 | MANAN PROSTATE SEEDING NEEDLE Manan Medical Products, Inc., Aug 10, 1990 |