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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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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. Class II

Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Cardinal Health 20121218 Terminated
Distributed: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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BS-200 Chemistry Analyzer Designed for clinical laboratory use. Class II

Reason: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

Mindray DS USA, Inc. d.b.a. Mindray North America 20121128 Terminated
Distributed: Distributed in the states of NC and TX.
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BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System. Class II

Reason: Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

Becton Dickinson & Co. 20121211 Terminated
Distributed: Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
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Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures. Class II

Reason: The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Orthohelix Surgical Designs Inc 20121030 Terminated
Distributed: Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
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