Recalls for Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

Due to finished goods incorrectly packaged and labeled.

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Product malfunction: Needle does not retract.

Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.