Recall Z-1693-2013— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2013-05-24, terminated 2019-10-07. It names 6 FDA 510(k) clearances: K120505, K113427, K111639 and 3 more. Product: 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. Reason: Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber).
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-24
- Terminated
- 2019-10-07
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
6 on FDA's record- K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
- K093902 — MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
- K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Data sourced from openFDA. This site is unofficial and independent of the FDA.