Reported Jun 12, 2024 · Ongoing
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
ARROW INTERNATIONAL Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARROW INTERNATIONAL Inc. · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Arrow FiberOptix
- Intra-Aortic Balloon Catheter Kit
a) REF IAB-05830-LWSb) REF IAB-05840-LWSc) REF IAB-05850-LWS
- Lot codes and dates
- 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)18F24C0185b) REF IAB-05840-LWS
- UDI
105 of 105 codes
(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)18F24D0055(01)10801902167733(17)260331(10)18F24D0072
- UDI(01)10801902167726(17)240831(10)18F22J0037(13)220927, (01)10801902167726(17)240831(10)18F22J0040(13)220929, (01)10801902167726(17)240930(10)18F22K0044(13)221021, (01)10801902167726(17)240930(10)18F22K0045(13)221021, (01)10801902167726(17)241031(10)18F22K0056(13)221028, (01)10801902167726(17)241031(10)18F22L0012(13)221104, (01)10801902167726(17)250930(10)18F23K0006(13)231031, (01)10801902167726(17)260131(10)18F24B0049(13)240227, (01)10801902167726(17)260228(10)18F24B0075(13)240301, (01)10801902172881(17)250930(10)18F23K0038(13)231028, (01)10801902172881(17)260228(10)18F24C0031(13)240316, (01)10801902172881(17)260228(10)18F24C0032(13)240331, (01)10801902172881(17)260228(10)18F24C0033(13)240315, (01)10801902172881(17)260228(10)18F24C0034(13)240315
- Amount recalled
- 7939 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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