Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam St...
FDA Recall #Z-0982-2013 — Class II — December 18, 2012
Product Description
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) 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. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Code Information
Catalog Number: 4FS60SSA Lot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated