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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where packaging defects potentially compromise sterility, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cardinal Health is recalling specific lots of sterile needle counters used for the disposal and counting of used surgical blades and needles. The recall involves two catalog numbers: 3FA70SSA (adhesive area) and 3FM70SSA (magnetic area). The affected units are 12.2 x 10.5 x 3.5 cm in size with a 40-count/70-capacity removable numbered foam block.
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 sterility of the product. The recall covers all lot numbers less than or equal to 843761 for catalog number 3FA70SSA and all lot numbers less than or equal to 933614 for catalog number 3FM70SSA.
The affected products were distributed nationwide in the United States, as well as in Australia, Canada, and Japan. The total quantity involved is 23,808 units of catalog number 3FA70SSA and 54,912 units of catalog number 3FM70SSA. Users should check their inventory for these specific catalog and lot numbers and stop using the affected devices.
The recalled product
- Product
- Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Pro
- 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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