Agency classClass IIOur severity:High FDA (Devices)·Z-0287-2016·Announced 2015-11-25

Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns

Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device where sterility cannot be assured, posing a risk of infection or harm without reported fatalities or specific injury counts.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling 508 boxes of the CIVCO Needle Guide Starter Kit. The product consists of a reusable non-sterile bracket with Infiniti Plus needle guides (12, 14, 16, 18GA) and is used in needle-guided or catheter procedures with diagnostic ultrasound transducers. The recall is being conducted because the sterility of the product cannot be assured.

The affected products were distributed nationwide in the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The specific reference numbers for the recalled items are 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, and 674-061.

Healthcare providers and consumers should stop using the affected products immediately. Users should check their inventory for the specific reference numbers and lot codes listed in the official recall notice. For more information, contact the recalling firm, Civco Medical Instruments Co. Inc.

The recalled product

Product: CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in…
Manufacturer: Civco Medical Instruments Co. Inc.
Category: Medical Device — Needle Guides
Hazard: sterility
infection-risk
Affected units: 508

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

M099850
M102860
M109690
M116920
M121840
M145200
M167240
M177420
M183850
M187880
M197330
M198000
M214900
M223090
M243020
M259940
M275080
M299890
M307610
M323480

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Civco Medical Instruments Co. Inc.

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Same hazard · sterility