Z-0568-2019Class II

CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with...

Name: Z-0568-2019 CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with...
Creator: CIVCO Medical Instruments Co., Inc.
Published: 2018-11-02
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2018-11-02 / Terminated

FDA source

CIVCO Medical Instruments Co., Inc. began a recall of CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle... on 2018-11-02. FDA classified it as Class II. As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0568-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-02
Posted: 2018-12-07
Terminated: 2020-11-20
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
Product code: ITX Transducer, Ultrasonic, Diagnostic
FDA root cause: Other
Action: The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory.
Quantity in commerce: 257 boxes
Distribution: Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
Product codes and lots: Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0562-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0563-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0564-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0565-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0566-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0567-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0568-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0569-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0570-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0571-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0572-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0573-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0574-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0575-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0576-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07

Product code ITX

K030064Class IIIlook 25 Needle Guide Attachment and Bracket AssemblySonosite,Inc. / cleared 2003-01-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)