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Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cu...

FDA Device Recall #Z-1876-2024 — Class I — February 26, 2024

Recall Summary

Recall Number Z-1876-2024
Classification Class I — Serious risk
Date Initiated February 26, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 168,632 tubes and 13,092 kits

Product Description

Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and (6) REF 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.

Reason for Recall

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.

Distribution Pattern

Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.

Lot / Code Information

UDI-DI numbers for the individual tubes: (1) DYNJ18860 - UDI-DI 20888277652672; (2) DYNJ18865 - UDI-DI 20888277652689; (3) DYNJ18870 - UDI-DI 20888277652696; (4) DYNJ18875 - UDI-DI 20888277652702; (5) DYNJ18880 - UDI-DI 20888277652719; (6) DYNJ18885 - UDI-DI 20888277657318. Kit code information: (1) Kit ACC010502 - Kit UDI-DI: 10193489846171; Case UDI-DI: 40193489846172; lot numbers: 23FDC233, 23FDB211, 23EDC153, 23EDB775, 23DDB280, 23CDB943, 23CDA556, 22LDA029, 22IDA550, 22HDA813, 22FDC033, 22CDC284, 21JDC054, 21IDB345, 21HDB405, and 21DDB305; (2) Kit ACC010527 - Kit UDI-DI: 10193489884333; Case UDI-DI: 40193489884334; 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; (3) Kit ACC10540 - Kit UDI-DI: 10193489977547; Case UDI-DI 40193489977548; lot number: 23ADB410; (4) Kit ACC10540A - Kit UDI-DI 10195327330088; Case UDI-DI 40195327330089; lot numbers: 23HDA588, 23GDB107, and 23BDA684; (5) Kit ACC010717 - Kit UDI-DI 10195327458997; Case UDI-DI 40195327458998; lot numbers: 24ADA577, 23LDA731, and 23IDA629; (6) Kit DYNDJ1132 - Kit UDI-DI 10195327454821; Case UDI-DI 40195327454822; lot numbers: 23LDA733, 23LDA617, 23JDC021, and 23HDA569; (7) Kit DYNDJ1133 - Kit UDI-DI 10195327428532; Case UDI-DI 40195327428533; lot numbers: 24BMB124, 23LMB682, 23HMF259, and 23HMD765; (8) Kit DYNJ909501 - Kit UDI-DI 10195327384852; Case UDI-DI 40195327384853; lot number: 23GBI504; (9) Kit DYNJ909501A - Kit UDI-DI 10195327549817; Case UDI-DI 40195327549818; lot numbers: 24BBD129, 24ABK281, and 23KBR773; (10) Kit DYNJAA269 - Kit UDI-DI 10195327209049; Case UDI-DI 40195327209040; lot numbers: 24BBE224, 24ABM718, 24ABD835, 23LBB055, 23JBP694, 23JBQ783, 23IBU821, 23IBF348, 23HBP188, 23CBX318, 23CBX319, 23BBR494, 23ABI514,22LBI988, 22KBH009, and 22JBH478.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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