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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 63951
Product Type Devices
Status Ongoing
Recalling Firm Cardinal Health
City Mc Gaw Park
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-18
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736 Z-0978-2013
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: FA40SSA Lot Numbers: lot number 763998 Catalog Number: 4FM40SSA Lot Numbers: all lot numbers less than or equal to 933099 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592 Z-0979-2013
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 4FS30SSA Lot Numbers: all lot numbers less than or equal to 848031 Catalog Number: 4FS31SSA Lot Numbers: lot number 739269 Catalog Number: 4MM30SSA Lot Numbers: all lot numbers less than or equal to 858154 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336 Z-0980-2013
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. 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 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384 Z-0981-2013
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. Catalog Number: 4FS60SSA Lot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184 Z-0982-2013
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FA70SSA Lot Numbers: all lot numbers less than or equal to 843761 Catalog Number: 3FM70SSA Lot Numbers: all lot numbers less than or equal to 933614 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 3FA70SSA: 23,808; Cat. No. 3FM70SSA: 54,912 Z-0983-2013
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FF80SSA Lot Numbers: all lot numbers less than or equal to 912899 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 3FF80SSA: 16224 Z-0984-2013
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. 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 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920 Z-0985-2013
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. Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cat. No. 4FM100SSA: 4,464 Z-0986-2013
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