CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues
CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.
What this means for you
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 identifies the issue as missing product labeling without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling errors or voluntary precautionary actions where harm has not been reported.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets, REF number P06013-08. 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 the affected brackets no longer have the required product labeling. The specific units involved include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as any brackets in inventory that lack product labeling. The recall status is currently Terminated.
Distribution of the affected products was made to the United States and 40 foreign countries, including Canada, Australia, China, Germany, Japan, and the United Kingdom. The recall was initiated by the firm and notified via letter. The recall was terminated on November 20, 2020.
The recalled product
- Product
- SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 115
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.
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