Z-0289-2016Class II

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12...

Name: Z-0289-2016 CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12...
Creator: Civco Medical Instruments Co. Inc.
Published: 2015-10-21
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2015-10-21 / Terminated / root cause: manufacturing process

FDA source

Civco Medical Instruments Co. Inc. began a recall of CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132... on 2015-10-21. FDA classified it as Class II and gives the reason as "Sterility of the product cannot be assured". 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-0289-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Posted: 2015-11-17
Terminated: 2017-02-28
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Sterility of the product cannot be assured.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email [email protected]. For questions regarding this recall call 319-248-6502.
Quantity in commerce: 206 boxes
Distribution: Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.
Product codes and lots: M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0286-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17
Z-0287-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17
Z-0288-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17
Z-0289-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17
Z-0290-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17

Product code ITX

K093713Class IIUltrasound General Purpose Guidance SystemCivco Medical Instruments / cleared 2010-01-19

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)