Reported Feb 1, 2023 · Ongoing
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b.…
Teleflex LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: TELEFLEX LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Endotracheal
- Tube labeled as the followinga. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
- Lot codes and dates
- a. Product Code
- Batch Number (UDI)504550, KME21D1964 ((01)4026704547579(17)260328(10)KME21D1964), 504560, KME21E1412 ((01)4026704547593(17)260428(10)KME21E1412), 504580, KME21D1784 ((01)4026704547630(17)260328(10)KME21D1784), 504580, KME21E1286 ((01)4026704547630(17)260428(10)KME21E1286), 504585, KME21E1295 ((01)4026704547647(17)260428(10)KME21E1295), 504590, KME21E1114 ((01)4026704547654(17)260428(10)KME21E1114); b. Product Code
- Batch Number (UDI)112082050, KME21F0727 ((01)14026704341389(17)260528(10)KME21F0727), 112082050, KME21F0321 ((01)14026704341389(17)260528(10)KME21F0321), 112082055, KME21E0864 ((01)14026704341396(17)260428(10)KME21E0864), 112082055, KME21F0946 ((01)14026704341396(17)260528(10)KME21F0946), 112082055, KME21E1230 ((01)14026704341396(17)260428(10)KME21E1230), 112082060, KME21E0660 ((01)14026704341402(17)260428(10)KME21E0660), 112082060, KME21E1391 ((01)14026704341402(17)260428(10)KME21E1391), 112082065, KME21E0607 ((01)14026704341419(17)260428(10)KME21E0607), 112082065, KME21E0685 ((01)14026704341419(17)260428(10)KME21E0685), 112082065, KME21F0384 ((01)14026704341419(17)260528(10)KME21F0384), 112082065, KME21F0516 ((01)14026704341419(17)260528(10)KME21F0516), 112082065, KME21F0694 ((01)14026704341419(17)260528(10)KME21F0694), 112082065, KME21F0834 ((01)14026704341419(17)260528(10)KME21F0834), 112082065, KME21F0930 ((01)14026704341419(17)260528(10)KME21F0930), 112082070, KME21D2935 ((01)14026704341426(17)260328(10)KME21D2935), 112082070, KME21E0002 ((01)14026704341426(17)260428(10)KME21E0002), 112082070, KME21E0363 ((01)14026704341426(17)260428(10)KME21E0363), 112082070, KME21E1390 ((01)14026704341426(17)260428(10)KME21E1390), 112082070, KME21D1580 ((01)14026704341426(17)260328(10)KME21D1580), 112082070, KME21D1652 ((01)14026704341426(17)260328(10)KME21D1652), 112082070, KME21D1706 ((01)14026704341426(17)260328(10)KME21D1706), 112082070, KME21D1878 ((01)14026704341426(17)260328(10)KME21D1878), 112082070, KME21D2020 ((01)14026704341426(17)260328(10)KME21D2020), 112082070, KME21D2929 ((01)14026704341426(17)260328(10)KME21D2929), 112082070, KME21E0001 ((01)14026704341426(17)260428(10)KME21E0001), 112082070, KME21F0102 ((01)14026704341426(17)260528(10)KME21F0102), 112082070, KME21F0140 ((01)14026704341426(17)260528(10)KME21F0140), 112082070, KME21F0239 ((01)14026704341426(17)260528(10)KME21F0239), 112082070, KME21F0434 ((01)14026704341426(17)260528(10)KME21F0434), 112082075, KME21E0288 ((01)14026704341433(17)260428(10)KME21E0288), 112082075, KME21E1150 ((01)14026704341433(17)260428(10)KME21E1150), 112082075, KME21E1178 ((01)14026704341433(17)260428(10)KME21E1178), 112082075, KME21E1186 ((01)14026704341433(17)260428(10)KME21E1186), 112082075, KME21F0557 ((01)14026704341433(17)260528(10)KME21F0557), 112082075, KME21D1705 ((01)14026704341433(17)260328(10)KME21D1705), 112082075, KME21D1780 ((01)14026704341433(17)260328(10)KME21D1780), 112082075, KME21D1923 ((01)14026704341433(17)260328(10)KME21D1923), 112082075, KME21D1956 ((01)14026704341433(17)260328(10)KME21D1956), 112082075, KME21D2014 ((01)14026704341433(17)260328(10)KME21D2014), 112082075, KME21D2018 ((01)14026704341433(17)260328(10)KME21D2018), 112082075, KME21D2262 ((01)14026704341433(17)260328(10)KME21D2262), 112082075, KME21E0021 ((01)14026704341433(17)260428(10)KME21E0021), 112082075, KME21E0498 ((01)14026704341433(17)260428(10)KME21E0498), 112082075, KME21E0469 ((01)14026704341433(17)260428(10)KME21E0469), 112082075, KME21F0351 ((01)14026704341433(17)260528(10)KME21F0351), 112082075, KME21E1264 ((01)14026704341433(17)260428(10)KME21E1264), 112082075, KME21F0184 ((01)14026704341433(17)260528(10)KME21F0184), 112082075, KME21F0385 ((01)14026704341433(17)260528(10)KME21F0385), 112082075, KME21F0594 ((01)14026704341433(17)260528(10)KME21F0594), 112082075, KME21F0725 ((01)14026704341433(17)260528(10)KME21F0725), 112082080, KME21D2012 ((01)14026704341440(17)260328(10)KME21D2012), 112082080, KME21F0981 ((01)14026704341440(17)260528(10)KME21F0981), 112082080, KME21D1653 ((01)14026704341440(17)260328(10)KME21D1653), 112082080, KME21D1946 ((01)14026704341440(17)260328(10)KME21D1946), 112082080, KME21D2011 ((01)14026704341440(17)260328(10)KME21D2011), 112082080, KME21E0584 ((01)14026704341440(17)260428(10)KME21E0584), 112082080, KME21E0687 ((01)14026704341440(17)260428(10)KME21E0687), 112082080, KME21E1452 ((01)14026704341440(17)260428(10)KME21E1452), 112082080, KME21E0770 ((01)14026704341440(17)260428(10)KME21E0770), 112082080, KME21F1006 ((01)14026704341440(17)260528(10)KME21F1006), 112082085, KME21E0902 ((01)14026704341457(17)260428(10)KME21E0902), 112082085, KME21E1291 ((01)14026704341457(17)260428(10)KME21E1291), 112082085, KME21F0741 ((01)14026704341457(17)260528(10)KME21F0741), 112082095, KME21E1393 ((01)14026704341471(17)260428(10)KME21E1393); c. Product Code
- Batch Number (UDI)112482065LA, KME21E0467 ((01)14026704629142(17)260428(10)KME21E0467), 112482070LA, KME21E0450 ((01)14026704629159(17)260428(10)KME21E0450), 112482075LA, KME21E0372 ((01)14026704629166(17)260428(10)KME21E0372), 112482075LA, KME21E0378 ((01)14026704629166(17)260428(10)KME21E0378), 112482075LA, KME21E0451 ((01)14026704629166(17)260428(10)KME21E0451), 112482075LA, KME21E0489 ((01)14026704629166(17)260428(10)KME21E0489), 112482080LA, KME21E0381 ((01)14026704629173(17)260428(10)KME21E0381), 112482085LA, KME21F0101 ((01)14026704629180(17)260528(10)KME21F0101), 112482085LA, KME21E0779 ((01)14026704629180(17)260428(10)KME21E0779),112482085LA, KME21E0956 ((01)14026704629180(17)260428(10)KME21E0956), 112482085LA, KME21F0520 ((01)14026704629180(17)260528(10)KME21F0520), 112482085LA, KME21F0637 ((01)14026704629180(17)260528(10)KME21F0637), 112482095LA, KME21E0742 ((01)14026704629203(17)260428(10)KME21E0742), 112482100LA, KME21D1667 ((01)14026704629210(17)260328(10)KME21D1667)
- Amount recalled
- 39,690 units
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
Why it was recalled
Potential for pilot balloon non-inflation or cuff non-deflation.
This product could cause temporary or reversible health problems — stop using it.
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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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