Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made

FDA device recall Z-1122-2012 · posted 2012-02-29 · Terminated

Recall details

Recalling firm

Mallinckrodt Inc

Reason for recall

The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.

Action taken

Covidien sent an Urgent Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product immediately. Customers were to use the attached business response form to report the quantity of each lot that is currently in their stock. If customers did not have any of these lots in stock, they should indicate by checking the appropriate box on the business report form. When completed, customers should email the completed form to covidien2600@stericycle.com or fax to 888-257-7910. For any questions customers should call 866-761-9571.

Root cause

Packaging process control

Status

Terminated

Product code

DXT

Distribution

Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N

Date initiated

2012-02-10

Date posted

2012-02-29

Date terminated

2013-12-24

Location

Cincinnati, OH

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