Endotracheal Tube Connector Disconnection Reported by Teleflex
Teleflex is recalling endotracheal tubes due to reports of disconnection between the tube and its 15mm connector. Affected devices were distributed nationwide including Puerto Rico.
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 establishes a minimum severity floor of 4 per the rubric rules. While the source text does not report actual injuries or deaths, the device failure (connector disconnection) involves a critical airway management device where malfunction could result in serious patient harm.
Plain-English summary
Teleflex LLC is recalling 3,590 endotracheal tubes (ETT) (oral/nasal uncuffed/plain - Magill, model REF 100380025) due to reports of disconnection between the tube and its 15mm connector.
The affected tubes were distributed nationwide in the United States, including Puerto Rico. The recalled batch numbers include: 19ET51, 19FT29, 19GT05, 19GT35, 19HT79, 19JT51, 19KT06, 19LT28, 20AT05, 20AT37, 20AT54, 20BG15, 20DT24, 20ET03, KME21B0529, KME21C0887, KME21D0327, KME21F0137, KME21K0799, KME21K0800, KME22A2704, KME22C0981, KME22C1568, KME22D0029, KME22H0686, KME22H1360. The product UDI/DI is 14026704340610.
Healthcare facilities and providers should immediately discontinue use of affected devices and consult with Teleflex or their medical device distributor with questions about this recall.
The recalled product
- Product
- Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
- airway-compromise
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 14026704340610
- Batch Numbers: 19ET51
- 19FT29
- 19GT05
- 19GT35
- 19HT79
- 19JT51
- 19KT06
- 19LT28
- 20AT05
- 20AT37
- 20AT54
- 20BG15
- 20DT24
- 20ET03
- KME21B0529
- KME21C0887
- KME21D0327
- KME21F0137
- KME21K0799
Distribution
Distributed nationwide across the United States.
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