Z-2242-2010

CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded...

Name: Z-2242-2010 CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded...
Creator: Civco Medical Instruments Inc
Published: 2010-07-20
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2010-07-20 / Terminated / root cause: manufacturing process

FDA source

Civco Medical Instruments Inc began a recall of CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The... on 2010-07-20. The reason FDA records is "Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2242-2010
Status: Terminated
Initiated: 2010-07-20
Posted: 2010-08-20
Terminated: 2012-04-13
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.
Quantity in commerce: 22 boxes
Distribution: Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
Product codes and lots: Lot M538160

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)