The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shap

FDA device recall Z-2081-2012 · posted 2012-07-26 · Terminated

Recall details

Recalling firm

Mallinckrodt Inc

Reason for recall

A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.

Action taken

Covidien send an Urgent Device Recall letter dated February 1, 2010, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and discontinue use of the product immediately. Customers were asked to complete the attached business form and report the quantity of affected product currently in their stock. Once the form is completed customers should fax the form to 314-654-8206. Once the business notification form is received, an RGA number will be sent to the customer for return of the product. Customers will receive credit for all returned product. For questions regarding this recall call the Product Monitoring Department at 800-778-7898. For questions about credit for the product, please call Customer Service at 888-774-1414, menu option 1, then menu option 2. For questions regarding this recall call 513-948-5719.

Root cause

Packaging process control

Status

Terminated

Product code

DXT

Quantity affected

75 cases (100 units per case)

Distribution

Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALI

Date initiated

2010-02-01

Date posted

2012-07-26

Date terminated

2012-08-03

Location

Cincinnati, OH

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