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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 Initiated by Firm December 18, 2012
Date Posted March 28, 2013
Recall Status1 Open3, Classified
Recall Number Z-0979-2013
Recall Event ID 63951
Product Classification Tray, surgical, instrument - Product Code FSM
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; Magnetic Area (Cat. No. 4FM40SSA)

Product Usage:
Disposal system for counting of used surgical blades and needles.
Code Information Catalog Number: FA40SSA, Lot Numbers: lot number 763998

Catalog Number: 4FM40SSA, Lot Numbers: all lot numbers less than or equal to 933099
Recalling Firm/
Manufacturer
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 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
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. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592
Distribution Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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