TELEFLEX LLC Recall 91301
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
TELEFLEX LLC Recall 91301 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1011-2023 |
| Event ID | 91301 |
| Event 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 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 39,690 units |
| Recall Reason | Potential for pilot balloon non-inflation or cuff non-deflation. |
| Device Classification | 20230201 |
| Device Code Info | 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) |
| Center Classification Date | 20230123 |
| Recall Initiation Date | 20221208 |
| Recalling Firm | TELEFLEX LLC |
| Initial Notification | Letter |
| Similar To |