FDA-Device2013-04-03Class II

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) 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. 4FM100SSA: 4,464
Manufactured in
1430 Waukegan Rd, Mc Gaw Park, IL, United States
Products
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) 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-0986-2013

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