Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides
Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides 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 involves a medical device where sterility cannot be assured, posing a risk of infection or harm during invasive procedures, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 54 boxes of CIVCO Sales Demo Kit Large Gauge Infiniti Plus Needle Guides. These devices are used in needle-guided or catheter procedures with diagnostic ultrasound transducers.
The recall was initiated because the sterility of the product cannot be assured. The affected products were distributed worldwide, including in the United States and numerous international locations such as Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected needle guides and contact Civco Medical Instruments for further instructions on how to return the product.
The recalled product
- Product
- CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device — Needle Guides
- Affected units
- 54
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)
- M116270
- M119900
- M121920
- M125640
- M130290
- M170900
- M185950
- M204790
- M211280
- M215550
- M235410
- M240880
- M252870
- M303130
- M320620
- M320660
- M346050
- M368820
- M379870
- M391260
Distribution
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.
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