Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0982-2013·Announced 2013-04-03

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 2/5 (Moderate).

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…
Manufacturer: Cardinal Health
Category: Medical Device — Surgical Disposal
Hazard: sterility-compromise
packaging-defect

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.

See all 9 products in this recall →

Same manufacturer · Cardinal Health

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Same hazard · sterility compromise