PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 3, 2013 Initiated: December 18, 2012 #Z-0984-2013

Product Description

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.

Reason for Recall

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Details

Recalling Firm
Cardinal Health
Units Affected
Cat. No. 3FF80SSA: 16224
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Location
Mc Gaw Park, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health. Units affected: Cat. No. 3FF80SSA: 16224.
Why was this product recalled?
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0984-2013.