Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Reason for recall: Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications. Distribution: US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT Quantity: 127,894 Lot/code info: REF/UI-DI: 5921-030-135/885825016142, 5921-030-235/885825016166, 5921-034-135/885825016173, 5921-034-235/885825016197, 5921-218-135/885825016500, 5921-218-235/885825016296 Lots: 0000202775, 0000209215, 0000202137, 0000201380, 0000200708, 13872322, 13453772, 0000198235, 0000202066, 0000209420, 0000206425, 0000192978, 0000202577, 0000192465, 13463347, 0000204578, 0000193181, 0000198446, 0000208949, 0000195337, 0000206263, 0000193179, 13486613, 0000202777, 0000195071, 0000204159, 0000195912, 0000200905, 0000206442, 0000197869, 13594486, 0000192979, 0000200706, 0000195068, 0000201379, 0000199502, 0000199434, 0000188863, 13493683, 0000193177, 0000202065, 0000200712, 0000200242, 0000202138, 13582864, 0000195075, 13570832, 0000199808, 0000202075, 0000195340, 0000200254, 0000202932, 13774680, 13851472, 13634704, 0000199819, 0000204319, 0000204160, 0000201378, 0000200227, 0000203311, 0000206583, 13235119, 0000194243, 0000196364, 0000193841, 0000200270, 13828088, 0000196363, 13392486, 13280380, 0000192981, 0000198461, 0000196361, 0000200244, 0000203310, 0000200229, 13398036, 13352572, 0000194232, 0000200253, 0000198245, 0000202776, 0000197373, 0000187746, 13765829, 13449838, 0000200256, 0000202145, 0000198246, 0000198236, 0000204574, 0000202143, 0000194242, 13583025, 0000202074, 0000203315, 0000195073, 0000193176, 0000212764, 0000196379, 13811283, 13605685, 0000187310, 0000208444, 0000204366, 0000197867, 13865381, 13820702, 0000176566, 13663274, 0000196365, 0000210787, 0000206440, 0000
885825016142, 885825016166, 885825016173, 885825016197, 885825016500, 885825016296
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.