FDA Recall
Terminated
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.
Recall: Z-1054-2008
·
Initiated January 16, 2008
Recall
- Recall Number
- Z-1054-2008
- Event Number
- 46743
- Firm
- Civco Medical Instruments Inc
- FEI Number
- 1937223
- Product Code
- ITX
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- January 16, 2008
- Posted
- March 19, 2008
- Terminated
- April 3, 2008
- Address
- 102 1st St S, Kalona, IA, 52247-9589
Description
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.
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).
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.
Distribution
Nationwide Distribution- including states of TX and GA
Quantity
Lot M102250 - 5 boxes; Lot M105440 - 2 boxes