CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 257 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, but the specific hazard is missing product labeling, which is a documentation issue rather than a direct physical or chemical hazard causing injury.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 257 boxes of CIVCO Needle Guide Starter Kits, reference numbers P12920-01 and P12920-02. The recall was initiated on November 2, 2018, and was terminated on November 20, 2020. The affected products are reusable non-sterile brackets with sterile needle guides and CIV-Flex covers 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 FDA classified this recall as Class II.
The products were distributed to various 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 providers should check their inventory for these specific lot numbers and brackets lacking labeling.
The recalled product
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 257
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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