U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate.
Company Name:
Medline Industries LP
Brand Name:
Brand Name(s)
Medline
Product Description:
Product Description
SubG Endotracheal Tubes with Subglottic Suction and kits that contain these devices

Company Announcement

On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate. It has also been reported that the main tube is susceptible to tearing. The primary health and safety risks due to these defects include increased risk of patient re-intubation, delay in case and/or treatment, respiratory distress from loss of ventilation, uncontrolled loss of airway gases, and, if the device comes apart during use, partial or total airway obstruction and choking. These may lead to inefficient ventilation or failure to ventilate and oxygenate, hypoxemia, carbon dioxide retention, acidemia, organ ischemia, cardiorespiratory arrest, regurgitation and aspiration of gastric contents, ventilator associated pneumonia, bradycardia, cardiac arrest, bleeding, tissue damage, and organ damage.

Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using and discard the device. No product is to be returned to Medline.

Recalled SubG Endotracheal Tube with Subglottic Suction were manufactured from March 01, 2021 to January 01, 2024 and distributed from March 01, 2021 to February 20, 2024.

The following kit/tray SKUs are included in the scope of the recall:

Name of Product

Model/Product Number

Lot Number

Expiration Date

UDI EA

UDI Case

INTUBATION KIT – DRAWER 3 ACC010502 23FDC233 2/29/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23FDB211 2/29/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23EDC153 1/31/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23EDB775 11/30/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23DDB280 1/31/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23CDB943 1/31/2024 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 23CDA556 12/31/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 22LDA029 12/31/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 22IDA550 6/30/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 22HDA813 6/30/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 22FDC033 6/30/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 22CDC284 2/28/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 21JDC054 2/28/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 21IDB345 2/28/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 21HDB405 2/28/2023 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010502 21DDB305 3/31/2022 10193489846171 40193489846172
INTUBATION KIT – DRAWER 3 ACC010527 23JDA443 7/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23IDA363 7/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23IDA232 7/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23HDC331 7/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23HDA117 6/30/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23GDB600 6/30/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23FDC372 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23FDB913 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23FDA966 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23FDA310 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23EDC371 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23EDC154 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23EDC094 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23EDB732 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23EDA387 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23CDB838 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23CDA557 1/31/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23BDC008 12/31/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23BDA945 2/29/2024 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 23ADB791 12/31/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 22LDA005 12/31/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 22JDB800 6/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 22HDB976 6/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 322HDA451 6/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 22GDB041 6/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21LDB937 4/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21LDB416 4/30/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21JDB262 9/30/2022 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21IDB491 2/28/2023 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21IDA193 9/30/2022 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21GDB207 12/31/2022 10193489884333 40193489884334
INTUBATION KIT – DRAWER 3 ACC010527 21FDC754 4/30/2022 10193489884333 40193489884334
ADULT INTUBATION ACC010540 23ADB410 5/31/2023 10193489977547 40193489977548
ADULT INTUBATION ACC010540 23HDA588 10/31/2024 10195327330088 40195327330089
ADULT INTUBATION ACC010540 23GDB107 8/31/2024 10195327330088 40195327330089
ADULT INTUBATION ACC010540 23BDA684 10/31/2024 10195327330088 40195327330089
AIRWAY KIT – DRAWER 3 ACC010717 24ADA577 12/31/2024 10195327458997 40195327458998
AIRWAY KIT – DRAWER 3 ACC010717 23LDA731 12/31/2024 10195327458997 40195327458998
AIRWAY KIT – DRAWER 3 ACC010717 23IDA629 7/31/2024 10195327330088 40195327330089
AIRWAY KIT DYNDJ1132 23LDA733 12/31/2024 10195327454821 40195327454822
AIRWAY KIT DYNDJ1132 23LDA617 12/31/2024 10195327454821 40195327454822
AIRWAY KIT DYNDJ1132 23JDC021 12/31/2024 10195327454821 40195327454822
AIRWAY KIT DYNDJ1132 23HDA569 7/31/2024 10195327454821 40195327454822
ADULT INTUBATION W EVAC DYNDJ1133 24BMB124 6/30/2026 10195327428532 40195327428533
ADULT INTUBATION W EVAC DYNDJ1133 23LMB682 4/30/2026 10195327428532 40195327428533
ADULT INTUBATION W EVAC DYNDJ1133 23HMF259 3/31/2026 10195327428532 40195327428533
ADULT INTUBATION W EVAC DYNDJ1133 23HMD765 12/31/2025 10195327428532 40195327428533
BACKUP KIT DYNJ909501 24BBD129 N/A 10195327384852 40195327384853
BACKUP KIT DYNJ909501A 23GBI504 12/31/2024 10195327549817 40195327549818
BACKUP KIT DYNJ909501A 24ABK281 12/31/2024 10195327549817 40195327549818
BACKUP KIT DYNJ909501A 23KBR773 12/31/2024 10195327549817 40195327549818
ADULT INTUBATION TRAY DYNJAA269 24BBE224 12/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 24ABM718 1/31/2025 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 24ABD835 11/30/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23LBB055 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23JBP694 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23JBQ783 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23IBU821 10/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23IBF348 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23HBP188 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23CBX318 2/29/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23CBX319 2/29/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23BBR494 9/30/2023 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 23ABI514 7/31/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 22LBI988 2/29/2024 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 22KBH009 8/31/2023 10195327209049 40195327209040
ADULT INTUBATION TRAY DYNJAA269 22JBH478 6/30/2023 10195327209049 40195327209040

Additionally, the following finished good SKUs are included in the scope of the recall:

Name of Product

Model/Product Number

Lot Number

UDI

TUBE, ENDOTRACHEAL, SUBG, 6.0 DYNJ18860 All Lots 20888277652672
TUBE, ENDOTRACHEAL, SUBG, 6.5 DYNJ18865 All Lots 20888277652689
TUBE, ENDOTRACHEAL, SUBG, 7.0 DYNJ18870 All Lots 20888277652696
TUBE, ENDOTRACHEAL, SUBG, 7.5 DYNJ18875 All Lots 20888277652702
TUBE, ENDOTRACHEAL, SUBG, 8.0 DYNJ18880 All Lots 20888277652719
TUBE, ENDOTRACHEAL, SUBG, 8.5 DYNJ18885 All Lots 20888277657318

Products can be identified by their product labeling, which will indicate the name of the device and product number (see “REF” for reference to the product number).

Medline Industries, LP voluntarily recalled product after performing a thorough investigation of complaints filed for this issue. Medline Industries, LP has notified the FDA of this action.

At this time, Medline Industries, LP is not aware of any serious health consequences which have occurred due to use of the device.

Medline Industries, LP distributed product(s) within the United States, El Salvador and United Arab Emirates. Medline Industries, LP is notifying its distributors and customers by email and/or first-class mail and is arranging for credit of all recalled product(s).

Consumers with questions regarding this recall can contact Medline Industries, LP by phone at 866-359-1704 or recalls@medline.com Monday through Friday between the hours of 8am and 5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this medical device.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Company Contact Information

Consumers:
Medline Industries, LP
866-359-1704
recalls@medline.com
 
Back to Top