Device product
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Z-0981-2013
Product summary
- Firm
- Cardinal Health
- Event
- Event 63951
- Status
- Terminated
- Classification
- Class II
- Quantity
- Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384
- Official record key
device-enforcement:Z-0981-2013
Official wording
Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Code information: Catalog Number: 3FS60SSA Lot Numbers: all lot numbers less than or equal to 898712 Catalog Number: 3FS61SSA Lot Numbers: all lot numbers less than or equal to 898714 Catalog Number: 3MM60SSA Lot Numbers: all lot numbers less than or equal to 931754
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.