CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-0
FDA device recall Z-1054-2008 · posted 2008-03-19 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).
- Action taken
- On 1/16/08, the recalling firm contacted their customers and notified them of the problem. Pictures of the problems were provided for identification. The firm requested that all products be returned.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- Lot M102250 - 5 boxes; Lot M105440 - 2 boxes
- Distribution
- Nationwide Distribution- including states of TX and GA
- Date initiated
- 2008-01-16
- Date posted
- 2008-03-19
- Date terminated
- 2008-04-03
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE (K970514) | CIVCO Medical Instruments Co., Inc. | 1997-06-20 |