RegWardenFDA facility compliance records
Facility

CareFusion 213 LLC

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

Activity by year

FDA actions on record by year2009: 1 recalls; 2013: 2 recalls; 2014: 1 recalls; 2016: 2 recalls, 1 inspections; 2017: 1 recalls; 2020: 2 recalls; 2021: 2 recalls; 2022: 4 recalls; 2023: 3 recalls, 1 inspections1’09’10’11’122’131’14’153’161’17’18’192’202’214’224’23’24’25’26
  • Recalls (18)
  • Inspections (2)

Devices registered here (2)

Recalls & enforcement

20233 records
  • 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.
20224 records
  • 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 to t…
  • Class IIOngoing2022-09-26
    Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
  • Class IIOngoing2022-08-01
    Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and …
  • Class IITerminated2022-02-23
    The finished device package did not contain the IFU.
20212 records
  • Class IIOngoing2021-08-02
    Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was …
  • Class IITerminated2021-06-09
    A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
20202 records
  • 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…
20171 record
20162 records
  • 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…
20141 record
  • 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.
20132 records
  • 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.
  • Class IIITerminated2013-03-04
    An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to …
20091 record
  • Class IITerminated2009-11-20
    The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

FDA inspections (2)

  • VAI2023-09-29
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • NAI2016-12-15
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CareFusion 213 LLC (FEI 3004932373) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004932373-carefusion-213-llc/

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