Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.

FDA device recall Z-0978-2013 · posted 2013-03-28 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FSM

Quantity affected

Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736

Distribution

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

Date initiated

2012-12-18

Date posted

2013-03-28

Date terminated

2016-08-01

Location

Park, IL