ARROW INTERNATIONAL Inc.: Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

Hazard

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Details from the source

Reason for recall: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway. Distribution: Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE. Quantity: 44,807 units Lot/code info: a) REF IAB-06830-U, UDI: (01)10801902161939(17)240731(10)18F22H0008, (01)10801902161939(17)241130(10)18F22M0019, (01)10801902161939(17)241231(10)18F23A0027, (01)10801902161939(17)241231(10)18F23A0039, (01)10801902161939(17)250131(10)18F23B0006, (01)10801902161939(17)250131(10)18F23B0020, (01)10801902161939(17)250131(10)18F23B0032, (01)10801902161939(17)250630(10)18F23G0066, (01)10801902161939(17)250731(10)18F23H0059, (01)10801902161939(17)250731(10)18F23H0070, (01)10801902161939(17)250731(10)18F23H0074, (01)10801902161939(17)250831(10)18F23J0046, (01)10801902161939(17)250930(10)18F23K0059, (01)10801902161939(17)251231(10)18F24A0036, (01)10801902161939(17)260331(10)18F24D0004, (01)10801902172898(17)240430(10)18F22E0062, (01)10801902172898(17)240531(10)18F22F0007, (01)10801902172898(17)240531(10)18F22F0017, (01)10801902172898(17)240531(10)18F22F0020, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)2

UPC codes

10801902161939, 10801902172898, 10801902161946, 10801902172904, 10801902144192, 10801902172911

Source

Official record: FDA (Device enforcement) ↗

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