Home / Recalls / Medical Devices
Cardinal Health recalls Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block;
Recalled April 3, 2013 · FDA recall Z-0985-2013 · Cardinal Health
Hazard
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. · FDA Class II
Units
Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920
Sold at
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Description
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Product
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Manufacturer(s)
Cardinal Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →