Baxter Healthcare Corporation: Device Recall

Recall Details

Recall Number

Z-2321-2024

Classification

Class I

Product Type

Device

Recalling Firm

Baxter Healthcare Corporation

Status

Ongoing

Date Initiated

05/30/2024

Location

Deerfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

58,220 units

Reason for Recall

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

Product Description

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.

Distribution Pattern

Nationwide distribution. International distribution to Canada, France, and Germany.

Other Recalls by Baxter Healthcare Corporation

• Class II: Risk 12/22/2025
  Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
• Class II: Risk 11/28/2025
  Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
• Class II: Risk 10/28/2025
  Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
• Class II: Risk 09/17/2025
  Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
• Class II: Risk 08/29/2025
  IV sets may leak.

View all recalls by Baxter Healthcare Corporation →