FDAFDA · Food and drugs·Recall number Z-0985-2013
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.
Published April 3, 2013 · Recall initiated: December 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health
- Distributor
- Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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