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Recall Observatory FDA recall evidence

Device product

Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

Z-0984-2013

December 18, 2012

Class II

Product summary

Firm
Cardinal Health
Event
Event 63951
Status
Terminated
Classification
Class II
Quantity
Cat. No. 3FF80SSA: 16224
Official record key
device-enforcement:Z-0984-2013

Official wording

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

Code information: Catalog Number: 3FF80SSA Lot Numbers: all lot numbers less than or equal to 912899

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.