TELEFLEX LLC: Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure

Hazard

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

Details from the source

Reason for recall: Potential for pilot balloon non-inflation or cuff non-deflation. 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 Salva Quantity: 497 units Lot/code info: Not distributed within the USA. a. Product Code, Batch Number (UDI): 112080-000065, KME21D2250 ((01)14026704195937(17)260328(10)KME21D2250), 112080-000080, KME21E1336 ((01)14026704195968(17)260428(10)KME21E1336); b. Product Code, Batch Number (UDI): 112082-000050, KME21F0726 ((01)14026704196019(17)260528(10)KME21F0726), 112082-000055, KME21E1231 ((01)14026704196026(17)260428(10)KME21E1231), 112082-000055, KME21F0945 ((01)14026704196026(17)260528(10)KME21F0945), 112082-000060, KME21E1395 ((01)14026704196033(17)260428(10)KME21E1395), 112082-000065, KME21F0383 ((01)14026704196040(17)260528(10)KME21F0383), 112082-000065, KME21F0833 ((01)14026704196040(17)260528(10)KME21F0833), 112082-000065, KME21F0931 ((01)14026704196040(17)260528(10)KME21F0931), 112082-000070, KME21E0582 ((01)14026704196057(17)260428(10)KME21E0582), 112082-000070, KME21E1267 ((01)14026704196057(17)260428(10)KME21E1267), 112082-000070, KME21E1350 ((01)14026704196057(17)260428(10)KME21E1350), 112082-000070, KME21F0435 ((01)14026704196057(17)260528(10)KME21F0435), 112082-000070, KME21E0683 ((01)14026704196057(17)260428(10)KME21E0683), 112082-000070, KME21E1183 ((01)14026704196057(17)260428(10)KME21E1183), 112082-000070, KME21E1266 ((01)14026704196057(17)260428(10)KME21E1266), 112082-000070, KME21E1289 ((01)14026704196057(17)260428(10)KME21E1289), 112082-000070, KME21F0008 ((01)14026704196057(17)260528(10)KME21F0008), 112082-000070, KME21F0836 ((01)14026704196057(17)260528(10)KME21F0836), 112082-000075, KME21D1576

UPC codes

14026704195937, 14026704195968, 14026704196019, 14026704196026, 14026704196033, 14026704196040, 14026704196057, 14026704196064, 14026704196071, 14026704196088, 14026704196330, 14026704196347, 14026704196361, 14026704196378, 14026704196385, 14026704196392, 14026704196408, 14026704196200, 14026704196217, 14026704196224, 14026704196231, 14026704196248, 14026704196255, 14026704196262, 14026704196279, 14026704196286, 14026704196293, 14026704196460, 14026704196477, 14026704196484, 14026704196491, 14026704196507, 14026704196514, 14026704196521, 140267041965

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.