FDA Device recall Z-2888-2018

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

FDA Device
Class II
terminated
Published 2018-08-29

On 2018-08-29 the FDA classified a Class II recall of CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound trans… by Civco Medical Instruments, citing A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2888-2018
Classification	Class II
Status	terminated
Initiated	2018-02-23
Published	2018-08-29
Last updated	2026-09-13 11:54 UTC
Company	Civco Medical Instruments
Distribution	US

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.

Reason

A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Identifiers

code_info	Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110,… 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, M0270

code_info

Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110,…

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, M0270

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-2888-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.