TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoad

FDA device recall Z-1325-2009 · posted 2009-06-05 · Terminated

Recall details

Recalling firm

MDS Canada Inc. DBA MDS Nordion

Reason for recall

Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.

Action taken

A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions. For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.com.

Root cause

Error in labeling

Status

Terminated

Product code

NAW

Quantity affected

26

Distribution

Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.

Date initiated

2009-02-24

Date posted

2009-06-05

Date terminated

2009-06-08

Location

Ottawa Canada, Ontario