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Terminated

Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T

FDA Recall Z-1693-2013 · Posted 2013-07-11

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2013-05-24
Date Terminated2019-10-07
Product Quantity725 units

Reason for Recall

Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

Firm Action

Fresenius notified customers on May 24, 2013, by telephone and by certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120505FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente · 2012-03-06K113427FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America · 2011-12-21K111639FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care · 2011-10-21K101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573Fresenius Medical Care North America, Design Cente · 2010-12-21K093902MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573Fresenius Medical Care North America · 2010-05-27K080964FRESENIUS 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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