🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: October 21, 2015 Civco Medical Instruments Co. Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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, M226140, M226800, M237170, M239790, M242650, M264850, M273010, M277260, M277580, M281220, M282340, M286970, M287050, M288070, M300220, M303390, M304830, M309930, M322420, M330620, M346280, M352800, M360970, M365460, M374640, M377700, M377710, M382140, M384960, M391930, M395520, M408990, M413270, M414570, M415150, M426920, M431600, M431860, M437370, M445090, M446780, M453070, M454110, M457210, M461430, M466270, M471250, M481240, M489250, M492210, M494110, M500070, M516520, M526820, M542120, M548580, M554010, M569710, M573220, M595220, M601030, M602270, M615780, M623480, M629400, M645460, M655810, M543860, M552040, M557840, M567820, M581180, M582540, M584460, M599110, and M609470
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Civco Medical Instruments Co. Inc.
Reason for Recall:
Sterility of the product cannot be assured.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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, M226140, M226800, M237170, M239790, M242650, M264850, M273010, M277260, M277580, M281220, M282340, M286970, M287050, M288070, M300220, M303390, M304830, M309930, M322420, M330620, M346280, M352800, M360970, M365460, M374640, M377700, M377710, M382140, M384960, M391930, M395520, M408990, M413270, M414570, M415150, M426920, M431600, M431860, M437370, M445090, M446780, M453070, M454110, M457210, M461430, M466270, M471250, M481240, M489250, M492210, M494110, M500070, M516520, M526820, M542120, M548580, M554010, M569710, M573220, M595220, M601030, M602270, M615780, M623480, M629400, M645460, M655810, M543860, M552040, M557840, M567820, M581180, M582540, M584460, M599110, and M609470

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0286-2016

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