CareFusion 213 LLC

13 recall(s) on record — most severe on record: Class I.

Devices registered here (2)

• Lavage, Jet
  Product code FQH · Class II · General Hospital · 21 CFR 880.5475
• Dressing, Wound, Drug
  Product code FRO · Unclassified · Unknown

Recalls & enforcement

• Class IIOngoing2023-07-13
  Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
• Class IIOngoing2023-03-16
  A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
• Class IIOngoing2023-01-30
  Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
• Class IIOngoing2022-11-02
  BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer
• Class IIOngoing2022-09-26
  Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
• Class IITerminated2022-02-23
  The finished device package did not contain the IFU.
• Class IITerminated2020-05-28
  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
• Class IITerminated2020-05-18
  Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially cau
• Class IITerminated2017-02-23
  The integrity of the sterile packaging is potentially compromised.
• Class ITerminated2016-07-01
  BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or o
• Class IITerminated2016-06-29
  The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the comp
• Class IITerminated2014-07-31
  The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
• Class IITerminated2013-08-28
  Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.

Related

• All facilities operated by CAREFUSION
• CAREFUSION 2200, INC. (IL)
• CAREFUSION 2200, INC. (OK)
• CareFusion D.R. 203 Ltd. (DO)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →