Elevated risk U.S. Food and Drug Administration

Medline SubG Endotracheal Tubes with Subglottic Suction and kits that contain recall: The inflation tube and other device components have become detached and/or

Recall published 2+ years ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
May 31, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Medline
Product type
Medical devices
UPC codes
10193489846171, 10193489884333, 10193489977547, 10195327330088, 10195327458997, 10195327454821

Products covered by this recall

SubG Endotracheal Tubes with Subglottic Suction and kits that contain these devices

What the company announced

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: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23FDC233 · Expiration Date: 2/29/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23FDB211 · Expiration Date: 2/29/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23EDC153 · Expiration Date: 1/31/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23EDB775 · Expiration Date: 11/30/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23DDB280 · Expiration Date: 1/31/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23CDB943 · Expiration Date: 1/31/2024 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 23CDA556 · Expiration Date: 12/31/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 22LDA029 · Expiration Date: 12/31/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 22IDA550 · Expiration Date: 6/30/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 22HDA813 · Expiration Date: 6/30/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 22FDC033 · Expiration Date: 6/30/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 22CDC284 · Expiration Date: 2/28/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 21JDC054 · Expiration Date: 2/28/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 21IDB345 · Expiration Date: 2/28/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 21HDB405 · Expiration Date: 2/28/2023 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010502 · Lot Number: 21DDB305 · Expiration Date: 3/31/2022 · UDI EA: 10193489846171 · UDI Case: 40193489846172
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23JDA443 · Expiration Date: 7/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23IDA363 · Expiration Date: 7/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23IDA232 · Expiration Date: 7/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23HDC331 · Expiration Date: 7/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23HDA117 · Expiration Date: 6/30/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23GDB600 · Expiration Date: 6/30/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23FDC372 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23FDB913 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23FDA966 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23FDA310 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23EDC371 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23EDC154 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23EDC094 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23EDB732 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23EDA387 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23CDB838 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23CDA557 · Expiration Date: 1/31/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23BDC008 · Expiration Date: 12/31/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23BDA945 · Expiration Date: 2/29/2024 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 23ADB791 · Expiration Date: 12/31/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 22LDA005 · Expiration Date: 12/31/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 22JDB800 · Expiration Date: 6/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 22HDB976 · Expiration Date: 6/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 322HDA451 · Expiration Date: 6/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 22GDB041 · Expiration Date: 6/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21LDB937 · Expiration Date: 4/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21LDB416 · Expiration Date: 4/30/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21JDB262 · Expiration Date: 9/30/2022 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21IDB491 · Expiration Date: 2/28/2023 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21IDA193 · Expiration Date: 9/30/2022 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21GDB207 · Expiration Date: 12/31/2022 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: INTUBATION KIT – DRAWER 3 · Model/Product Number: ACC010527 · Lot Number: 21FDC754 · Expiration Date: 4/30/2022 · UDI EA: 10193489884333 · UDI Case: 40193489884334
  • Name of Product: ADULT INTUBATION · Model/Product Number: ACC010540 · Lot Number: 23ADB410 · Expiration Date: 5/31/2023 · UDI EA: 10193489977547 · UDI Case: 40193489977548
  • Name of Product: ADULT INTUBATION · Model/Product Number: ACC010540 · Lot Number: 23HDA588 · Expiration Date: 10/31/2024 · UDI EA: 10195327330088 · UDI Case: 40195327330089
  • Name of Product: ADULT INTUBATION · Model/Product Number: ACC010540 · Lot Number: 23GDB107 · Expiration Date: 8/31/2024 · UDI EA: 10195327330088 · UDI Case: 40195327330089
  • Name of Product: ADULT INTUBATION · Model/Product Number: ACC010540 · Lot Number: 23BDA684 · Expiration Date: 10/31/2024 · UDI EA: 10195327330088 · UDI Case: 40195327330089
  • Name of Product: AIRWAY KIT – DRAWER 3 · Model/Product Number: ACC010717 · Lot Number: 24ADA577 · Expiration Date: 12/31/2024 · UDI EA: 10195327458997 · UDI Case: 40195327458998
  • Name of Product: AIRWAY KIT – DRAWER 3 · Model/Product Number: ACC010717 · Lot Number: 23LDA731 · Expiration Date: 12/31/2024 · UDI EA: 10195327458997 · UDI Case: 40195327458998
  • Name of Product: AIRWAY KIT – DRAWER 3 · Model/Product Number: ACC010717 · Lot Number: 23IDA629 · Expiration Date: 7/31/2024 · UDI EA: 10195327330088 · UDI Case: 40195327330089
  • Name of Product: AIRWAY KIT · Model/Product Number: DYNDJ1132 · Lot Number: 23LDA733 · Expiration Date: 12/31/2024 · UDI EA: 10195327454821 · UDI Case: 40195327454822
  • Name of Product: AIRWAY KIT · Model/Product Number: DYNDJ1132 · Lot Number: 23LDA617 · Expiration Date: 12/31/2024 · UDI EA: 10195327454821 · UDI Case: 40195327454822
  • Name of Product: AIRWAY KIT · Model/Product Number: DYNDJ1132 · Lot Number: 23JDC021 · Expiration Date: 12/31/2024 · UDI EA: 10195327454821 · UDI Case: 40195327454822
  • Name of Product: AIRWAY KIT · Model/Product Number: DYNDJ1132 · Lot Number: 23HDA569 · Expiration Date: 7/31/2024 · UDI EA: 10195327454821 · UDI Case: 40195327454822

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 48 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10193489846171
  • 10193489884333
  • 10193489977547
  • 10195327330088
  • 10195327458997
  • 10195327454821

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 23FDC233
  • 23FDB211
  • 23EDC153
  • 23EDB775
  • 23DDB280
  • 23CDB943
  • 23CDA556
  • 22LDA029
  • 22IDA550
  • 22HDA813
  • 22FDC033
  • 22CDC284
  • 21JDC054
  • 21IDB345
  • 21HDB405
  • 21DDB305
  • 23JDA443
  • 23IDA363
  • 23IDA232
  • 23HDC331

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2/29/2024
  • 1/31/2024
  • 11/30/2024
  • 12/31/2023
  • 6/30/2023
  • 2/28/2023
  • 3/31/2022
  • 7/31/2024
  • 6/30/2024
  • 4/30/2023
  • 9/30/2022
  • 12/31/2022
  • 4/30/2022
  • 5/31/2023
  • 10/31/2024
  • 8/31/2024
  • 12/31/2024

Model or item number

On the rating label, the box or the instruction sheet.

  • ACC010502
  • ACC010527
  • ACC010540
  • ACC010717
  • DYNDJ1132

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Remedy named in the notice: Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using and discard the device.

Company contact: Medline Industries LP — Consumers: Medline Industries, LP, 866-359-1704, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489846171, 10193489884333, 10193489977547; lot code 23FDC233, 23FDB211, 23EDC153; best-by date 2/29/2024 or 1/31/2024; model number ACC010502, ACC010527, ACC010540. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using and discard the device.

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