Z-1607-2011

CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The...

Name: Z-1607-2011 CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The...
Creator: Civco Medical Instruments Inc
Published: 2011-01-21
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2011-01-21 / Terminated / root cause: labeling and UDI

FDA source

Civco Medical Instruments Inc began a recall of CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA on 2011-01-21. The reason FDA records is "Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1607-2011
Status: Terminated
Initiated: 2011-01-21
Posted: 2011-03-08
Terminated: 2013-07-09
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.
Quantity in commerce: 31/24-cover boxes
Distribution: Nationwide Distribution -- WA, CA, and MO.
Product codes and lots: Lots M615880, M598520, M591150, and M581180.

Product code ITX

K013721Class IISynthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. / cleared 2001-12-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)