Cardinal Health Recalls Needle Counters Due to Packaging Sterility Concerns
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
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 the hazard involves a potential compromise of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health is recalling 4,464 units of Needle Counters with Blade Disarmer (Catalog Number 4FM100SSA). The recall affects all lot numbers less than or equal to 847028. These devices are sterile disposal systems used for counting used surgical blades and needles.
The recall was initiated because small holes, approximately 1 mm or less, were found in the device unit level packaging. These defects potentially compromise the product's sterility.
The affected products were distributed nationwide in the United States, as well as in Australia, Canada, and Japan. Users should stop using the affected devices and contact Cardinal Health for further instructions.
The recalled product
- Product
- Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
- Manufacturer
- Cardinal Health
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cardinal Health 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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