Medline Sub-G Endotracheal Tubes with Subglottic Suctioning—Inflation and Suction Defects
Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which by rule requires a minimum score of 4. The defect affects a critical airway management device used in ventilated patients. Potential consequences include loss of ventilation control and inability to maintain airway pressure, which could result in serious patient harm, though no patient injuries have been reported in the source text.
Plain-English summary
Medline Industries is recalling Medline Sub-G Endotracheal Tubes with Subglottic Suctioning (individual tube models REF DYNJ18860 through DYNJ18885) and accompanying convenience kits containing these tubes.
The devices have defects in which the inflation tube may detach from or tear away from the main tube, potentially resulting in moisture buildup, loss of pressure, or inability to inflate. The suction pump may also be difficult to connect or may detach during use.
Approximately 168,632 individual tubes and 13,092 kits have been distributed nationwide, including to government and military facilities. Additional units were distributed to San Salvador and the United Arab Emirates.
Healthcare providers and patients should immediately discontinue use of affected devices and notify their supplier or healthcare facility. Affected products can be identified using the UDI-DI numbers and lot numbers provided in the official FDA recall notice.
The recalled product
- Product
- 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, Po
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- Case UDI-DI: 40193489846172
- lot numbers: 23FDC233
- 23FDB211
- 23EDC153
- 23EDB775
- 23DDB280
- 23CDB943
- 23CDA556
- 22LDA029
- 22IDA550
- 22HDA813
- 22FDC033
- 22CDC284
- 21JDC054
- 21IDB345
Distribution
Distributed nationwide across the United States.
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