Recall Z-0986-2013 ยท FSM Tray, Surgical, Instrument
Cardinal Health
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.
| Date | Mar 28, 2013 (initiated Dec 18, 2012) |
| Status | Terminated |
| Reason | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. |
| Root cause | 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 80 |
| Quantity | Cat. No. 4FM100SSA: 4,464 |
| Distribution | Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.