Z-1400-2015Class II

CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with...

Name: Z-1400-2015 CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with...
Creator: Civco Medical Instruments Inc
Published: 2015-02-26
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2015-02-26 / Terminated / root cause: manufacturing process

FDA source

Civco Medical Instruments Inc began a recall of CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is... on 2015-02-26. FDA classified it as Class II and gives the reason as "Leaks were detected in the recalled lot which may compromise the sterility of the product". 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-1400-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-04-08
Terminated: 2017-02-28
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Leaks were detected in the recalled lot which may compromise the sterility of the product.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or [email protected].
Quantity in commerce: 120 pouches
Distribution: Distributed to the states of CA, IL, MA, MI, MO, and WI.
Product codes and lots: Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1400-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)