Device establishmentActive, RegisteredFDA warning letter on file
FRESENIUS KABI WARRENDALE
FRESENIUS KABI WARRENDALE is an FDA-registered device establishment (FEI 3005778453) located in WARRENDALE, Pennsylvania. The facility is active, registered. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
Jan 4, 2024CGMP/QSR/Medical Devices/Adulterated
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Recalls (8)
Nov 21, 2025 Class IIEmphasizing instructions for LVP duration programming located in the IFU.
Ongoing
Nov 14, 2025 Class ISoftware version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Ongoing
Nov 3, 2025 Class IIDownstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Ongoing
Nov 3, 2025 Class IIncorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Ongoing
Sep 3, 2025 Class IIPotential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Ongoing
Jun 24, 2025 Class IIPotential for external cassette leaks
Ongoing
May 12, 2025 Class IMis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Ongoing
Jan 10, 2025 Class ILarge Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70
Ongoing
Recall data from openFDA enforcement reports (FDA Recall Enterprise System).
Establishment record
Address
770 Commonwealth Dr, WARRENDALE, Pennsylvania
Establishment type
Device establishment
Products / operations
Hematology; Manufacture Medical Device
Registration status
Active, Registered
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Inspection history
Inspections on file
None on file
Form 483 observations
None on file
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
Questions
Is FRESENIUS KABI WARRENDALE registered with the FDA?
Yes. FRESENIUS KABI WARRENDALE is an FDA-registered device establishment (FEI 3005778453) in WARRENDALE, Pennsylvania. Its current registration status is Active, Registered.
Has FRESENIUS KABI WARRENDALE received an FDA warning letter?
Yes. FDA issued a warning letter to FRESENIUS KABI WARRENDALE; the most recent is dated Jan 4, 2024 (CGMP/QSR/Medical Devices/Adulterated).
What does FRESENIUS KABI WARRENDALE do?
FRESENIUS KABI WARRENDALE's FDA-registered operations are: Hematology; Manufacture Medical Device.
Source: FDA public data · status as of 2026-06-01