Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub
FDA device recall Z-0922-05 · posted 2005-06-22 · Terminated
Recall details
- Recalling firm
- Manan Medical Products, Inc.
- Reason for recall
- The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
- Action taken
- 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
- Status
- Terminated
- Product code
- KXK
- Quantity affected
- 22,900 units
- Distribution
- Florida and Georgia
- Date initiated
- 2005-05-03
- Date posted
- 2005-06-22
- Date terminated
- 2005-08-29
- Location
- Wheeling, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANAN PROSTATE SEEDING NEEDLE (K902622) | Manan Medical Products, Inc. | 1990-08-10 |