CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.
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 explicitly states the reason is a labeling defect (missing product labeling) and does not report any illnesses or injuries. This aligns with the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where the hazard is not a direct physical injury risk but a compliance/identification issue.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 66 boxes of CIVCO Needle Guide Starter Kits, reference numbers P12924-01 and P12924-02. The recall was initiated on November 2, 2018, and was classified as Class II by the FDA. 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 recall is due to a labeling defect where some 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 missing the product labeling. The recall status is currently terminated.
The affected products were distributed to numerous 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. The source text does not specify if the products were distributed within the United States.
Healthcare providers and consumers should check their inventory for the specific lot numbers and reference numbers listed above. If the product matches the description and lot numbers, it should be removed from use. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, 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, 22 GAUGE, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 66
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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