Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 Pack, Sterile, Terumo Cardiova

FDA device recall Z-2617-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's manufacturing process.

Action taken

Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 3, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were sent 10 replacement pressure monitoring kits with the removal notice as immediate replacements. The firm will send additional replacements to customers that have more than 10 units of affected product as noted on the Customers' returned reponse form. Customers that received the custom packs were provided stickers to identify the recalled packs. The customers were instructed not to open the packs to remove the affected pressure monitoring kit prior to clinical use, but to replace the pressure domes at the time of use. For more information please contact Terumo Cardiovascular Customer Service at 800- 521-2818.

Root cause

Other

Status

Terminated

Product code

DTQ

Quantity affected

1515 ALL CUSTOM PACKS

Distribution

Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa R

Date initiated

2011-05-03

Date posted

2011-06-22

Date terminated

2012-07-18

Location

Ann Arbor, MI

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