Recall Z-0984-2013— Cardinal Health

Name: FDA recall Z-0984-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-18

Class II · Terminated

Class II FDA medical device recall by Cardinal Health, initiated 2012-12-18, terminated 2016-08-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility..

Recalling firm: Cardinal Health
Classification: Class II
Status: Terminated
Initiated: 2012-12-18
Terminated: 2016-08-01
Firm location: Mc Gaw Park, IL, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.