Endotracheal Tube labeled as the following: a. 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
Enforcement
- Recall Number
- Z-1011-2023
- Event ID
- 91301
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TELEFLEX LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 1, 2023
- Initiation Date
- December 8, 2022
- Classification Date
- January 23, 2023
- Address
- 3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States
Description
Endotracheal Tube labeled as the following: a. 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
Potential for pilot balloon non-inflation or cuff non-deflation.
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)
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.
39,690 units