FDA Device Recall Z-1876-2024

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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.

Lot / serial / GTIN: 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.

Quantity: 168,632 tubes and 13,092 kits

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.

Recall record

Recall number: Z-1876-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.
Recall initiated: 2024-02-26
Classified by FDA Center: 2024-05-28
FDA published: 2024-06-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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