||March 28, 2013
|Recall Event ID
Tray, surgical, instrument -
||Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA)
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA)
Disposal system for counting of used surgical blades and needles.
||Catalog Number: 3FS60SSA
Lot Numbers: all lot numbers less than or equal to 898712
Catalog Number: 3FS61SSA
Lot Numbers: all lot numbers less than or equal to 898714
Catalog Number: 3MM60SSA
Lot Numbers: all lot numbers less than or equal to 931754
1430 Waukegan Rd
Mc Gaw Park
|For Additional Information Contact
||Michele B. Donatich, R.N.
|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.
|Quantity in Commerce
||Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384
||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.