Cardinal Health: Medical Device Recall in 2013 - (Recall #: Z-0981-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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) Product Usage: Disposal system for counting of used surgical blades and needles.

Product Classification:

Class II

Date Initiated: December 18, 2012

Date Posted: April 3, 2013

Recall Number: Z-0981-2013

Event ID: 63951

Reason for Recall:

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Status: Terminated

Product Quantity: Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384

Code Information:

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

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated