FDA (Devices) recall action 63951

Cardinal Health recalled 9 products on 2013-04-03

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-04-03
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–9 of 9

ModerateFDA (Devices)··2013-04-03
Cardinal Health Recalls Needle Counters Due to Packaging Sterility Concerns
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
Product
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 Co
Category
Distribution
0 states
HighFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall covers units distributed in the US, Australia, Canada, and Japan.
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
Category
Distribution
0 states
HighFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
Product
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) Pro
Category
Distribution
0 states
HighFDA (Devices)··2013-04-03
Cardinal Health Recalls Needle Counters Due to Packaging Defects
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
Product
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; Mag
Category
Distribution
0 states
HighFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
Product
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; M
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
Product
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; Dou
Category
Distribution
0 states
HighFDA (Devices)··2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
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) Prod
Category
Distribution
0 states