FDA-Device2013-04-03Class II
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Cardinal Health
Hazard
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Sold states
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Affected count
Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736
Manufactured in
1430 Waukegan Rd, Mc Gaw Park, IL, United States
Products
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2013Don't want to check this manually?
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