RecallRadar

FDA Device recall Z-0572-2019

CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 1…

On 2018-12-19 the FDA classified a Class II recall of CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 1… by Civco Medical Instruments.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0572-2019
ClassificationClass II
Statusterminated
Initiated2018-11-02
Published2018-12-19
Last updated2026-09-13 11:54 UTC
CompanyCivco Medical Instruments
Distributionn/a

Product

CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..

Reason

Identifiers

code_infoBoxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2019%22

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