Z-0986-2013 Class II Terminated
FDA device recall Z-0986-2013 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. 4FM100SSA: 4,464.
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. 4FM100SSA: 4,464
Product Description
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.
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: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0986-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026