PlainRecalls
FDA Devices Moderate Class II Terminated

Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting

Reported: April 3, 2013 Initiated: December 18, 2012 #Z-0980-2013

Product Description

Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) 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.

Details

Recalling Firm
Cardinal Health
Units Affected
Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336
Distribution
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Location
Mc Gaw Park, IL

Frequently Asked Questions

What product was recalled? ▼
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles.. Recalled by Cardinal Health. Units affected: Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336.
Why was this product recalled? ▼
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0980-2013.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →