The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0566-2019·Announced 2018-12-19

CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects

CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units 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 or injuries. The hazard is limited to missing product labeling, which aligns with the rubric for moderate severity involving labeling errors or low-risk issues without reported harm.

Plain-English summary

CIVCO Medical Instruments Co., Inc. is voluntarily recalling 297 boxes of SonoSite Needle Guide Brackets, reference numbers P06013-06 and P06013-07. These are reusable, non-sterile brackets designed for use with SonoSite L25 series transducers. The recall was initiated on November 2, 2018, and was classified as Class II by the FDA.

The reason for the recall is that some brackets in inventory no longer have the required product labeling. The affected units include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as any brackets in inventory that have lost their labeling. The FDA has not reported any illnesses or injuries associated with this recall.

The affected products were distributed in the United States and to numerous foreign countries, including Canada, Australia, China, Germany, Japan, and the United Kingdom. Users should check their inventory for these specific reference numbers and lot ranges. If the product labeling is missing, the brackets should be removed from use and returned to CIVCO Medical Instruments. The recall was terminated on November 20, 2020.

The recalled product

Product
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
Manufacturer
CIVCO Medical Instruments Co., Inc.
Category
Medical Device — Ultrasound Accessories
Hazard
Affected units
297

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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