Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
Bard Access Systems is recalling MiniLoc Safety Infusion Sets because some units have needle lengths and gauges that differ from the label descriptions.
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 discrepancy regarding needle specifications. This aligns with the rubric for moderate severity, as it is a labeling error without reported injuries or deaths.
Plain-English summary
Bard Access Systems is conducting a voluntary field action for the MiniLoc Safety Infusion Set Winged without Y-Injection Site (Product Code: S02022-75). The recall also involves the SafeStep Huber Needle Set with Y-Injection Site. The action is being taken because some sets may contain units where the needle length and gauge differ from the specifications described on the label.
The affected products are intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. The recall covers 7,200 units, specifically Lot Numbers ASAQS0343 and ASZIS027. These products were distributed worldwide and nationwide in the United States, including in California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Maryland, New Jersey, Ohio, Oregon, and Texas.
Healthcare facilities and distributors should check their inventory for the specific lot numbers and product codes listed above. If the affected products are found, they should be removed from use and returned to Bard Access Systems according to the instructions provided in the recall notice.
The recalled product
- Product
- MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood samplin
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 7,200
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 (1)
- Lot Numbers: ASAQS0343 & ASZIS027
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bard Access Systems 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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