Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab...
FDA Recall #Z-0985-2013 — Class II — December 18, 2012
Product Description
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.
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. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Code Information
Catalog Number: 4FA70SSA Lot Numbers: all lot numbers less than or equal to 931750 Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated