Z-0978-2013 Class II Terminated
FDA device recall Z-0978-2013 was initiated by Cardinal Health on Dec 18, 2012 and is designated Class II. Reason for recall: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. The recall status is terminated (terminated Aug 1, 2016). Affected quantity: Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2013
- Initiation Date
- Dec 18, 2012
- Termination Date
- Aug 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736
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.
Reason for Recall
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Distribution Pattern
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0978-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026