CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as compon

FDA device recall Z-2950-2011 · posted 2011-08-04 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Corporation

Reason for recall

Reservoir blood bag used in cardiovascular procedures may leak.

Action taken

Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTN

Quantity affected

253 reservoirs

Distribution

(USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.

Date initiated

2011-07-21

Date posted

2011-08-04

Date terminated

2012-02-10

Location

Elkton, MD