FDAFDA · Food and drugs·Recall number Z-0982-2013
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.
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: 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.