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.
Recall
- Recall Number
- Z-0979-2013
- Event Number
- 63951
- Firm
- Cardinal Health
- FEI Number
- 3001236905
- Product Code
- FSM
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- December 18, 2012
- Posted
- March 28, 2013
- Terminated
- August 1, 2016
- Address
- 1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726
Description
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.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
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.
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Cat. No. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592