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U.S. Department of Health and Human Services

Class 2 Device Recall Needle Counters

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 Class 2 Recall
Needle Counters
see related information
Date Posted March 28, 2013
Recall Status1 Open
Recall Number Z-0982-2013
Recall Event ID 63951
Product Classification Tray, Surgical, Instrument - Product Code FSM
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 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.
Code Information 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
Recalling Firm/
Manufacturer
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park, Illinois 60085-6726
For Additional Information Contact Michele B. Donatich, R.N.
847-473-1500
Manufacturer Reason
for Recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.
Quantity in Commerce Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184
Distribution Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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