FDAFDA · Food and drugs·Recall number Z-1878-2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Published June 12, 2024 · Recall initiated: April 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Distributor
- 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.
- Lot
- a) REF IAB-05830-LWS, UDI: (01)10801902161892(17)241231(10)18F23A0038, (01)10801902161892(17)250131(10)18F23B0023, (01)10801902161892(17)250430(10)18F23D0024, (01)10801902161892(17)250731(10)18F23H0060, (01)10801902161892(17)250930(10)18F23J0075, (01)10801902161892(17)250930(10)18F23K0013, (01)10801902161892(17)251031(10)18F23L0019, (01)10801902161892(17)251031(10)18F23L0041, (01)10801902161892(17)260131(10)18F24B0008, (01)10801902161892(17)260228(10)18F24C0058, (01)10801902161892(17)260228(10)18F24C0101, (01)10801902161892(17)260331(10)18F24D0002, (01)10801902172843(17)250228(10)18F23C0026, (01)10801902172843(17)250531(10)18F23F0049, (01)10801902172843(17)250831(10)18F23J0001, (01)10801902172843(17)251031(10)18F23L0054, (01)10801902172843(17)251130(10)18F23M0056, (01)10801902172843(17)251231(10)18F24A0015, (01)10801902172843(17)260131(10)18F24A0040, (01)10801902172843(17)260131(10)18F24B0013, (01)10801902172843(17)260228(10)18F24C0061, (01)10801902172843(17)260228(10)18F24C0109, (01)10801902172843(17)260228(10)18F24C0110, (01)10801902172843(17)260331(10)18F24C0172, (01)10801902172843(17)260331(10)18F24C0173, (01)10801902172843(17)46112(10)18F24C0088, (01)10801902172843(17)46112(10)18F24C0089, (01)10801902172843(17)46112(10)18F24C0174, (01)10801902172843(17)46112(10)18F24C0175, (01)10801902172843(17)46112(10)18F24C0176, (01)10801902172843(17)46112(10)18F24C0185; b) REF IAB-05840-LWS, UDI: (01)10801902167733(17)240531(10)18F22F0072, (01)10801902167733(17)240630(10)18F22G0021, (01)10801902167733(17)240630(10)18F22G0031, (01)10801902167733(17)240630(10)18F22G0046, (01)10801902167733(17)240731(10)18F22H0009, (01)10801902167733(17)240731(10)18F22H0023, (01)10801902167733(17)240731(10)18F22H0058, (01)10801902167733(17)240930(10)18F22K0015, (01)10801902167733(17)241130(10)18F22M0017, (01)10801902167733(17)241130(10)18F22M0018, (01)10801902167733(17)241231(10)18F23A0004, (01)10801902167733(17)241231(10)18F23A0005, (01)10801902167733(17)241231(10)18F23A0018, (01)10801902167733(17)241231(10)18F23A0026, (01)10801902167733(17)250131(10)18F23B0008, (01)10801902167733(17)250131(10)18F23B0016, (01)10801902167733(17)250531(10)18F23E0054, (01)10801902167733(17)250630(10)18F23G0017, (01)10801902167733(17)250731(10)18F23H0029, (01)10801902167733(17)250731(10)18F23H0064, (01)10801902167733(17)251031(10)18F23L0009, (01)10801902167733(17)251031(10)18F23L0028, (01)10801902167733(17)251231(10)18F23M0068, (01)10801902167733(17)251231(10)18F24A0030, (01)10801902167733(17)251231(10)18F24A0039, (01)10801902167733(17)260131(10)18F24B0015, (01)10801902167733(17)260131(10)18F24B0031, (01)10801902167733(17)260228(10)18F24C0008, (01)10801902167733(17)260228(10)18F24C0069, (01)10801902167733(17)260228(10)18F24C0071, (01)10801902167733(17)260228(10)18F24C0072, (01)10801902167733(17)260228(10)18F24C0075, (01)10801902167733(17)260228(10)18F24C0076, (01)10801902167733(17)260228(10)18F24C0077, (01)10801902167733(17)260228(10)18F24C0078, (01)10801902167733(17)260228(10)18F24C0079, (01)10801902167733(17)260228(10)18F24C0080, (01)10801902167733(17)260228(10)18F24C0081, (01)10801902167733(17)260331(10)18F24C0083, (01)10801902167733(17)260331(10)18F24C0186, (01)10801902167733(17)260331(10)18F24C0187, (01)10801902167733(17)260331(10)18F24C0188, (01)10801902167733(17)260331(10)18F24C0193, (01)10801902167733(17)260331(10)18F24D0020, (01)10801902167733(17)260331(10)18F24D0021, (01)10801902167733(17)260331(10)18F24D0022, (01)10801902167733(17)260331(10)18F24D0031, (01)10801902167733(17)260331(10)18F24D0032, (01)10801902167733(17)260331(10)18F24D0037, (01)10801902167733(17)260331(10)18F24D0038, (01)10801902167733(17)260331(10)18F24D0039, (01)10801902167733(17)260331(10)18F24D0042, (01)10801902167733(17)260331(10)18F24D0044, (01)10801902167733(17)260331(10)18F24D0045, (01)10801902167733(17)260331(10)18F24D0049, (01)10801902167733(17)260331(10)18F24D0050, (01)10801902167733(17)260331(10)18F24D0051, (01)10801902167733(17)260331(10)18F24D0054, (01)10801902167733(17)260331(10)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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