Fresenius Kabi Warrendale
Warrendale, PA, US
FRESENIUS KABI WARRENDALE appears in FDA device records in Warrendale, PA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Fresenius Kabi Warrendale carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Fresenius Medical Care Holdings, Inc. dba Renal Solutionsenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005778453 | 3005778453 | FRESENIUS KABI WARRENDALE | 770 Commonwealth Dr, WARRENDALE, PA 15086 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MMHBlood Establishment Computer Software And Accessories
- LWEBone Marrow Collection/Transfusion Kit
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- KSQDevice, Blood Mixing And Blood Weighing
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PHCInfusion Safety Management Software
- FRNPump, Infusion
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- GKTSeparator, Automated, Blood Cell, Diagnostic
- FPASet, Administration, Intravascular
- KSSSupplies, Blood-Bank
- LNRSystem, Photopheresis, Extracorporeal
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2082-2013 | 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician. | Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain