Reported Jun 5, 2024 · Ongoing
Medline Sub-G Endotracheal Tube with Subglottic Suctioning
MEDLINE INDUSTRIES, LP - Northfield
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Medline Sub-G Endotracheal Tube with Subglottic Suctioning
6 of 6 products
| Model / number | Product as published |
|---|---|
DYNJ18860 | Polyurethane Cuff 6.0 mm ID; (2) |
DYNJ18865 | Polyurethane Cuff 6.5 mm ID; (3) |
DYNJ18870 | Polyurethane Cuff 7.0 mm ID; (4) |
DYNJ18875 | Polyurethane Cuff 7.5 mm ID; (5) |
DYNJ18880 | Polyurethane Cuff 8.0 mm ID; and (6) |
DYNJ18885 | Polyurethane Cuff 8.5 mm ID. Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits: (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case; (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case; (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case; (6) Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case; (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case; (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case. |
- Lot codes and dates
35 of 35 products
Products covered by this recall # Barcodes Product as published 1 20888277652672(1) DYNJ18860 - UDI-DI 20888277652672 2 20888277652689(2) DYNJ18865 - UDI-DI 20888277652689 3 20888277652696(3) DYNJ18870 - UDI-DI 20888277652696 4 20888277652702(4) DYNJ18875 - UDI-DI 20888277652702 5 20888277652719(5) DYNJ18880 - UDI-DI 20888277652719 6 2088827765731810193489846171(6) DYNJ18885 - UDI-DI 20888277657318. Kit code information: (1) Kit ACC010502 - Kit UDI-DI: 10193489846171 7 40193489846172Case UDI-DI: 40193489846172 8 lot numbers: 23FDC233, 23FDB211, 23EDC153, 23EDB775, 23DDB280, 23CDB943, 23CDA556, 22LDA029, 22IDA550, 22HDA813, 22FDC033, 22CDC284, 21JDC054, 21IDB345, 21HDB405, and 21DDB305 9 10193489884333(2) Kit ACC010527 - Kit UDI-DI: 10193489884333 10 40193489884334Case UDI-DI: 40193489884334 11 lot numbers: 23JDA443, 23IDA363, 23IDA232, 23HDC331, 23HDA117, 23GDB600, 23FDC372, 23FDB913, 23FDA966, 23FDA310, 23EDC371, 23EDC154, 23EDC094, 23EDB732, 23EDA387, 23CDB838, 23CDA557, 23BDC008, 23BDA945, 23ADB791, 22LDA005, 22JDB800, 22HDB976, 22HDA451, 22GDB041, 21LDB937, 21LDB416, 21JDB262, 21IDB491, 21IDA193, 21GDB207, and 21FDC754 12 10193489977547(3) Kit ACC10540 - Kit UDI-DI: 10193489977547 13 40193489977548Case UDI-DI 40193489977548 14 lot number: 23ADB410 15 10195327330088(4) Kit ACC10540A - Kit UDI-DI 10195327330088 16 40195327330089Case UDI-DI 40195327330089 17 lot numbers: 23HDA588, 23GDB107, and 23BDA684 18 10195327458997(5) Kit ACC010717 - Kit UDI-DI 10195327458997 19 40195327458998Case UDI-DI 40195327458998 20 lot numbers: 24ADA577, 23LDA731, and 23IDA629 - Amount recalled
- 168,632 tubes and 13,092 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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