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U.S. Department of Health and Human Services

Class 2 Device Recall Needle Counters

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 Class 2 Device Recall Needle Counters see related information
Date Posted March 28, 2013
Recall Status1 Open
Recall Number Z-0986-2013
Recall Event ID 63951
Product Classification Tray, surgical, instrument - Product Code FSM
Product Needle Counters with Blade Disarmer; 12.2 x 10.5 x 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.
Code Information Catalog Number: 4FM100SSA
Lot Numbers: all lot numbers less than or equal to 847028
Recalling Firm/
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich, R.N.
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
Package 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. 4FM100SSA: 4,464
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.