CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary 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 due to missing product labeling, which aligns with the rubric criterion for 'Minor labeling errors' and 'voluntary precautionary recalls' where no specific injury or illness is reported.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 20 boxes of CIVCO Needle Guide Starter Kits, REF 674-039. The recall was initiated on November 2, 2018, and was terminated on November 20, 2020. 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 recall was initiated because some boxes and brackets in inventory no longer have the product labeling. The specific units affected include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as all brackets in inventory that lack product labeling. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed in the United States and to 40 foreign countries, including Canada, Australia, Germany, Japan, and the United Kingdom. The recall status is currently Terminated. Consumers and healthcare providers should check their inventory for the specific lot numbers listed or for brackets missing product labeling and contact CIVCO Medical Instruments for further instructions.
The recalled product
- Product
- CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 20
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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