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Recall Observatory FDA recall evidence

Device product

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.

Z-0986-2013

December 18, 2012

Class II

Product summary

Firm
Cardinal Health
Event
Event 63951
Status
Terminated
Classification
Class II
Quantity
Cat. No. 4FM100SSA: 4,464
Official record key
device-enforcement:Z-0986-2013

Official wording

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

Code information: Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028

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.