Recall Z-0982-2013— Cardinal Health
Class II · Terminated
Class II FDA medical device recall by Cardinal Health, initiated 2012-12-18, terminated 2016-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility..
- Recalling firm
- Cardinal Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-18
- Terminated
- 2016-08-01
- Firm location
- Mc Gaw Park, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.