Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered F...
FDA Recall #Z-0984-2013 — Class II — December 18, 2012
Product Description
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) 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. 3FF80SSA: 16224
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Code Information
Catalog Number: 3FF80SSA Lot Numbers: all lot numbers less than or equal to 912899
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated