Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
This recall has been terminated (originally issued March 28, 2013).
- Company
- Cardinal Health
- Recall Initiated
- December 18, 2012
- Posted
- March 28, 2013
- Terminated
- August 1, 2016
- Recall Number
- Z-0985-2013
- Quantity
- Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Lot / Code Info
Catalog Number: 4FA70SSA Lot Numbers: all lot numbers less than or equal to 931750 Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173
Root Cause
Package design/selection
Action Taken
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.