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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description 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.
Recall Number Z-0982-2013
Classification Class II
Code Info 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
Product Distributed Qty Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184
Reason For Recall Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

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.
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