Device product
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.
Z-0978-2013
Product summary
- Firm
- Cardinal Health
- Event
- Event 63951
- Status
- Terminated
- Classification
- Class II
- Quantity
- Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736
- Official record key
device-enforcement:Z-0978-2013
Official wording
Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Code information: Catalog Number: 3FA40SSA Lot Numbers: all lot numbers less than or equal to 928782 Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379
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.