Recall Z-1054-2008 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Inc
CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.
| Date | Mar 19, 2008 (initiated Jan 16, 2008) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Packaging |
| Action | 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. |
| Quantity | Lot M102250 - 5 boxes; Lot M105440 - 2 boxes |
| Distribution | Nationwide Distribution- including states of TX and GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO Medical Instruments Co., Inc., Jun 20, 1997 |