Home / Recalls / TELEFLEX LLC / Z-1011-2023

Z-1011-2023 Class II Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-1011-2023 was initiated by TELEFLEX LLC on Dec 8, 2022 and is designated Class II. Reason for recall: Potential for pilot balloon non-inflation or cuff non-deflation. The recall status is ongoing. Affected quantity: 39,690 units.

Recall Details

Product Type: Devices
Report Date: Feb 1, 2023
Initiation Date: Dec 8, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39,690 units

Product 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

Reason for Recall

Potential for pilot balloon non-inflation or cuff non-deflation.

Distribution Pattern

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.

Code Information

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)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1011-2023
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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