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Terminated

2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

FDA Recall Z-1550-2015 · Posted 2015-04-29

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-02-20
Date Terminated2021-05-18
Product Quantity133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)

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.

Firm Action

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: [email protected] 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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-12-06K120505FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente · 2012-03-06K120017FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-02-02K113427FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America · 2011-12-21K080964FRESENIUS MODEL 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America · 2009-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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