Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Remova...
FDA Recall #Z-0986-2013 — Class II — December 18, 2012
Product Description
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.
Reason for Recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Recalling Firm
Cardinal Health — Mc Gaw Park, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Cat. No. 4FM100SSA: 4,464
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Code Information
Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated