Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part

FDA device recall Z-2261-2013 · posted 2013-09-20 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Medical device used in cardiovascular procedures is defective.

Action taken

Terumo Cardiovascuolar Services sent recall letters to Chief of Perfusion, Director of Operating Room Services, Director of Biomedical Services, and Risk Management departments on July 26, 2013. The notifications advised that filters are being recalled because some of the filters may exhibit a partial or full occlusion of an outlet or purge port. Terumo CVS advised users to stop using Terumo AL6X arterial filters from the affected lot numbers for replacement. A supply of replacement filters for customer's immediate use accompanied the notification. For users ordering the AL6X filters as part of a Cardiovascular Procedure Kit, Terumo CVS is providing a preliminary supply of replacement Terumo AL6X arterial filters in which users may follow the instructions to replace the filter or users may return the Cardiovascular Procedure Kit and Terumo CVS will replace the filter for them. Customers with questions were advised to contact Terumo CVS Customer Service at 800-521-2818. For questions regarding this recall call 800-521-2818.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTM

Quantity affected

15,817 filters

Distribution

Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.

Date initiated

2013-07-26

Date posted

2013-09-20

Date terminated

2015-07-28

Location

Elkton, MD