Facility

SUNMED GROUP HOLDINGS, LLC dba AirLife

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

Key facts

6recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3030308442
Establishment type	Repack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	15152 W. Camelback Rd. Litchfield Park, AZ, US 85340
Registration status	Active · expires 2026
Parent company	SunMed Group Holdings, LLC dba AirLife (owner-operator 10044795)
Brand names	TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Activity by year

Recalls (6)

Devices registered here (1)

Tube, Aspirating, Flexible, Connecting
Product code BYY (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6740

Recalls & enforcement

Class IOngoing2025-12-15
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IOngoing2025-05-15
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant h…
Class IOngoing2025-05-01
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequence…
Class IIOngoing2023-10-11
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIOngoing2022-12-22
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Class IITerminated2022-09-08
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

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. “SUNMED GROUP HOLDINGS, LLC dba AirLife (FEI 3030308442) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030308442-sunmed-group-holdings-llc-dba-airlife/

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