Device product
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Z-0986-2013
Product summary
- Firm
- Cardinal Health
- Event
- Event 63951
- Status
- Terminated
- Classification
- Class II
- Quantity
- Cat. No. 4FM100SSA: 4,464
- Official record key
device-enforcement:Z-0986-2013
Official wording
Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Code information: Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028
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.