The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0571-2019·Announced 2018-12-19

CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling

CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to missing labeling, which fits the criteria for a moderate severity recall involving minor labeling errors or voluntary precautionary actions without reported harm.

Plain-English summary

CIVCO Medical Instruments Co., Inc. is voluntarily recalling 468 boxes of CIVCO Needle Guide Starter Kits, REF 674-037. The recall was initiated on November 2, 2018, and classified as Class II by the FDA. The affected product is a reusable non-sterile bracket with sterile needle guides and a CIV-Flex cover, intended for use with SonoSite L25 series transducers.

The reason for the recall is that some brackets in inventory no longer have the product labeling. The recall includes boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as all brackets in inventory that no longer have the product labeling. The recall was initiated by the firm and is voluntary.

The product was distributed to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom. The recall status is Terminated as of November 20, 2020.

The recalled product

Product
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
Manufacturer
CIVCO Medical Instruments Co., Inc.
Category
Medical Device — Needle Guide
Hazard
Affected units
468

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 (4)

  • Boxes with lot numbers between A000012-A050663
  • M000880-M995980
  • and P022503
  • and all brackets in inventory that no longer have the product labeling.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 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 15 products in this recall →

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