2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System -

FDA device recall Z-1550-2015 · posted 2015-04-29 · Terminated

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Action taken

The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.

Root cause

Software design

Status

Terminated

Product code

KDI

Quantity affected

133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.

Date initiated

2015-02-20

Date posted

2015-04-29

Date terminated

2021-05-18

Location

Waltham, MA

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