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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for sharps disposal, which presents a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Cardinal Health is recalling specific lots of sterile needle counters (Catalog Nos. 3FA40SSA and 3FM40SSA) 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, which is used as a disposal system for counting used surgical blades and needles.
The recall includes 23,952 units of Catalog No. 3FA40SSA and 140,736 units of Catalog No. 3FM40SSA. Affected lot numbers are those less than or equal to 928782 for the adhesive area version and less than or equal to 911379 for the magnetic area version. The products were distributed nationwide in the United States as well as in Australia, Canada, and Japan.
Healthcare facilities and consumers should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to the distributor or Cardinal Health according to their instructions.
The recalled product
- Product
- Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)…
- 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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