Cardinal Health: Medical Device Recall in 2013 - (Recall #: Z-0978-2013)

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; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) 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-0978-2013

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. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736

Code Information:

Catalog Number: 3FA40SSA Lot Numbers: all lot numbers less than or equal to 928782 Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated