FDA Device recall Z-0286-2016

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236

FDA Device
Class II
terminated
Published 2015-11-25

On 2015-11-25 the FDA classified a Class II recall of CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236 by Civco Medical Instruments, citing sterility of the product cannot be assured.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0286-2016
Classification	Class II
Status	terminated
Initiated	2015-10-21
Published	2015-11-25
Last updated	2026-09-13 11:53 UTC
Company	Civco Medical Instruments
Distribution	US

Product

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Reason

Sterility of the product cannot be assured.

Identifiers

code_info	M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M1… M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M113720, M122370, M153900, M206940, M250330, M250340, M258890, M315660, M333490, M340650, M340660, M418340, M421310, M450400, M465510, M473820, M499620, M519670, M519870, M535840, M560410, M569020, M665970, M085160, M096150, M107000, M130450, M155430, M163490, M203230, M215600, M237160, M280540, M295050, M309920, M315640, M335660, M341050, M395150, M426910, M432250, M445050, M447240, M447250, M457880, M463120, M470960, M472370, M491520, M501960, M572330, M610070, M623730, M626290, M648050, M104430, M105580, M109480, M119300, M123880, M181980, M183080, M205350, M208730, M256600, M288450, M395680, M419700, M490030, M511200, M524900, M530460, M636260, M070240, M084610, M087950, M090510, M093250, M096160, M107010, M113740, M122150, M126430, M130960, M142760, M150120, M151000, M161360, M162170, M175800, M176090, M179600, M188560, M197540, M201760, M204920, M206920, M212520, M

code_info

M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M1…

M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M113720, M122370, M153900, M206940, M250330, M250340, M258890, M315660, M333490, M340650, M340660, M418340, M421310, M450400, M465510, M473820, M499620, M519670, M519870, M535840, M560410, M569020, M665970, M085160, M096150, M107000, M130450, M155430, M163490, M203230, M215600, M237160, M280540, M295050, M309920, M315640, M335660, M341050, M395150, M426910, M432250, M445050, M447240, M447250, M457880, M463120, M470960, M472370, M491520, M501960, M572330, M610070, M623730, M626290, M648050, M104430, M105580, M109480, M119300, M123880, M181980, M183080, M205350, M208730, M256600, M288450, M395680, M419700, M490030, M511200, M524900, M530460, M636260, M070240, M084610, M087950, M090510, M093250, M096160, M107010, M113740, M122150, M126430, M130960, M142760, M150120, M151000, M161360, M162170, M175800, M176090, M179600, M188560, M197540, M201760, M204920, M206920, M212520, M

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2016%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.