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Recall Observatory FDA recall evidence

Device product

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

Z-0982-2013

December 18, 2012

Class II

Product summary

Firm
Cardinal Health
Event
Event 63951
Status
Terminated
Classification
Class II
Quantity
Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184
Official record key
device-enforcement:Z-0982-2013

Official wording

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

Code information: Catalog Number: 4FS60SSA Lot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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