CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.
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 and involves a labeling defect (missing product labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 613 boxes of CIVCO Needle Guide Starter Kits, REF 674-038. The recall was initiated on November 2, 2018, and 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 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 lacking product labeling. The products were distributed to the United States and 39 foreign countries, including Canada, Australia, and the United Kingdom.
The recall status is Terminated as of November 20, 2020. Consumers and healthcare providers should check their inventory for the specific lot numbers listed or for brackets missing product labeling. If affected products are found, they should be returned to CIVCO Medical Instruments Co., Inc. or the original supplier.
The recalled product
- Product
- CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 613
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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