Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Reported: April 3, 2013 Initiated: December 18, 2012 #Z-0978-2013
Product Description
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) 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.
Details
- Recalling Firm
- Cardinal Health
- Units Affected
- Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736
- Distribution
- Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
- Location
- Mc Gaw Park, IL
Frequently Asked Questions
What product was recalled? ▼
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.. Recalled by Cardinal Health. Units affected: Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736.
Why was this product recalled? ▼
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0978-2013.
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