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, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cardinal Health is recalling its sterile needle counters (Catalog No. 3FF80SSA) due to a packaging defect. The recall involves 16,224 units of the 40-count/80-capacity disposal system 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 holes potentially compromise the sterility of the product. The affected lot numbers are all lot numbers less than or equal to 912899.
The affected products were distributed nationwide in the United States, as well as in Australia, Canada, and Japan. Users should stop using the affected needle counters and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) 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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