Z-2888-2018Class II

CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use...

Name: Z-2888-2018 CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use...
Creator: Civco Medical Instruments Co. Inc.
Published: 2018-02-23
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2018-02-23 / Terminated / root cause: design

FDA source

Civco Medical Instruments Co. Inc. began a recall of CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product... on 2018-02-23. FDA classified it as Class II and gives the reason as "A cover failed leak testing during validation testing of new needle guides from a replacement tool". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2888-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-08-22
Terminated: 2020-10-06
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Root cause tag: design
FDA root cause: Device Design
Action: Telephone Script to be read: CIVCO is calling to notify our customers regarding a recall action being initiated. CIVCO has recently discovered a dimensional issue in our Infiniti bracket which may allow the needle guide to a puncture a cover. You are being notified, as your facility has been identified as having received product from one of the affected manufacturing lots. Advise on Action to be taken by Customer or Distributor: To return Infiniti needle guide, contact your Account Representative at 800-445-6741 or 319-248-6757. Alternately you may also use email at [email protected] to schedule the return of your device. Additional information to obtain: Verification of Email contact to send notification letter and response letter.
Quantity in commerce: 177 boxes
Distribution: Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
Product codes and lots: Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110, M119380, M605540, M706720, M570610, M543670, M851530, M983170, M358570. M358570, M427660. M526300, M526300, M734570, M912740, and M664690. Item 698-009: Biopsy Starter Kit for use with Zonare C9-3 transducers M427370, M103030, A010473, M103030, M771190, M427390, M293590, M427370, M105150, M089260, M515370, M293580, M888920, M427370, M220960, M558420, M560740, M909270, M096330, M388690, M558220, M695400, M085550, M917410, M419650, M879530, M964370, M093020, M723180, and A010459 Item: 698-016 Biposy Bracket for use with Zonare C9-3 transducers M567620 and M052860 Item 620-116 Biopsy Starter Kit for use with BK Medical 18L5 and 8870 transducers M080890, M559550, M425050, M056610, M092800, M041630, M186540, M122250, M335740, M043310, M499390, M483250, M109060, M275630, M912150, A023904, M457560, M051670, M091360, M895560, A015235, M202260, M869430, M056610, M027090, M308820, M831280, M547370, M253050, M083160, and M865470

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2888-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2888-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-22

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)