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Terminated

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.

FDA Recall Z-0986-2013 · Posted 2013-03-28

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeFSM
Date Initiated2012-12-18
Date Terminated2016-08-01
Product QuantityCat. No. 4FM100SSA: 4,464

Reason for Recall

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

Firm Action

Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.

Root Cause

Package design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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