Agency classClass IIOur severity:High FDA (Devices)·Z-0981-2013·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 covers 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 involves a risk-of-harm product (sterile medical device) where the defect (packaging holes) potentially compromises sterility, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Cardinal Health is recalling specific lots of sterile needle counters, including catalog numbers 3FS60SSA, 3FS61SSA, and 3MM60SSA. These products are disposal systems 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 defects potentially compromise the sterility of the products.

The affected units were distributed worldwide, specifically in the United States (nationwide), Australia, Canada, and Japan. The recall includes specific lot numbers for each catalog number: all lot numbers less than or equal to 898712 for 3FS60SSA, less than or equal to 898714 for 3FS61SSA, and less than or equal to 931754 for 3MM60SSA. The total quantity involved is 7,560 units of 3FS60SSA, 14,184 units of 3FS61SSA, and 12,384 units of 3MM60SSA.

Healthcare facilities and consumers should check their inventory for these specific catalog and lot numbers. If the products are found, they should be removed from use and returned to Cardinal Health or the distributor in accordance with the recall instructions.

The recalled product

Product: Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)…
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