Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
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 is a potential sterility compromise due to packaging defects. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health is recalling specific lots of sterile Needle Counters with Blade Disarmer. The recall is due to small holes, approximately 1 mm or less, found in the device unit-level packaging. These defects potentially compromise the sterility of the product.
The affected products include catalog numbers 4FS60SSA, 4FS61SSA, and 4MM60SSA. The recall covers specific lot numbers for each catalog number: all lot numbers less than or equal to 752068 for 4FS60SSA, less than or equal to 802581 for 4FS61SSA, and less than or equal to 898715 for 4MM60SSA. The total quantity involved is 576 units of 4FS60SSA, 14,760 units of 4FS61SSA, and 5,184 units of 4MM60SSA.
These products were distributed nationwide in the United States, as well as in Australia, Canada, and Japan. The devices are used as a disposal system for counting used surgical blades and needles. Users should check their inventory for the affected catalog and lot numbers and stop using the products if they match the recall criteria.
The recalled product
- Product
- Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Co
- 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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