Z-0564-2019Class II

CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e...

Name: Z-0564-2019 CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e...
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 / root cause: sterility

FDA source

CIVCO Medical Instruments Co., Inc. began a recall of CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA on 2018-11-02. FDA classified it as Class II and gives the reason as "The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0564-2019
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 Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Root cause tag: sterility
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: 948 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-0564-2019
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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)