Device product
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.
Z-0985-2013
Product summary
- Firm
- Cardinal Health
- Event
- Event 63951
- Status
- Terminated
- Classification
- Class II
- Quantity
- Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920
- Official record key
device-enforcement:Z-0985-2013
Official wording
Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Code information: 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
Distribution pattern: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Derived failure modes
-
Unknown
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.