Fresenius Kabi USA

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Potential for external cassette leaks

Potential for external cassette leaks

Potential for external cassette leaks

Potential for external cassette leaks

Mis-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.

Large 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 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Defective container: Cracked vials leading to lack of sterility assurance

Low out of specification results for epinephrine assay.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Cross Contamination with other products: trace amounts of lidocaine

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Cross Contamination with other products: trace amounts of lidocaine

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Presence of Particulate Matter; glass particulates

Failed Impurities/Degradation Specifications.

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Subpotent Drug

Failed Impurities/Degradation Specifications

Presence of Particulate Matter: Glass particulate found in sterile injectable product

Failed Impuities/Degradation Specifications

Failed Impuities/Degradation Specifications

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

The lot failed pH specification.

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Defective Container: Vials may be missing stoppers.

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Subpotent; 18 month time point

Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

Subpotent Drug; 15-month stability test station

Failed Impurities/Degradation Specification

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials