Z-1054-2008

CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer...

Name: Z-1054-2008 CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer...
Creator: Civco Medical Instruments Inc
Published: 2008-01-16
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2008-01-16 / Terminated / root cause: packaging

FDA source

Civco Medical Instruments Inc began a recall of 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... on 2008-01-16. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1054-2008
Status: Terminated
Initiated: 2008-01-16
Posted: 2008-03-19
Terminated: 2008-04-03
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: 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.
Product code: ITX Transducer, Ultrasonic, Diagnostic
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).
Root cause tag: packaging
FDA 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 in commerce: Lot M102250 - 5 boxes; Lot M105440 - 2 boxes
Distribution: Nationwide Distribution- including states of TX and GA
Product codes and lots: Lot Numbers:M102250 and M105440

Product code ITX

K970514Class IIDisposable Transrectal/transvaginal/endocavity Ultrasound Needle Instrument GuideCIVCO Medical Instruments Co., Inc. / cleared 1997-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)