CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
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 a labeling defect (missing product labeling on brackets). The rubric assigns a score of 2 for minor labeling errors and voluntary precautionary recalls where no specific injury or illness is reported in the source text.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 234 boxes of CIVCO Needle Guide Starter Kits, reference numbers P12922-01 and P12922-02. The recall was initiated on November 2, 2018, and was terminated on November 20, 2020. The product consists of a reusable non-sterile bracket with sterile needle guides and CIV-Flex covers, intended for use with SonoSite L25 series transducers.
The recall was issued because some brackets in inventory no longer have the product labeling. The affected units include 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 FDA classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed to facilities in the United States and foreign countries, including 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. Consumers and healthcare facilities should check their inventory for the specific lot numbers and reference numbers listed above and contact CIVCO Medical Instruments for further instructions.
The recalled product
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 234
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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