Device Recall Arrow International, Inc.

  • Model / Serial
    Lot Number: 18F14M0001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Belgium
  • Product Description
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr || Product Code: IAB-05840-LWS || The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

15 devices with a similar name

Learn more about the data here

  • Model / Serial
    Material Nos.:  ASK-04001-DU4 ASK-04001-DU5 ASK-04001-DU6 ASK-04001-DU6 ASK-04001-DU7 ASK-04001-DU8 ASK-35052-JHVA1 ASK-45041-JHVA CDC-44041-VPS CDC-35063-VPS CDC-35541-VPS CDC-35552-VPS CDC-35563-VPS CDC-44041-VPS CDC-45541-VPS VPS7220B CDC-34041-VPS CDC-34052-VPS CDC-34063-VPS CDC-35041-VPS CDC-35041-VPS CDC-35052-VPS CDC-35063-VPS ASK-04001-DU5 CDC-45041-VPS ASK-04001-UOC ASK-35041-JHVA ASK-35052-JHVA CDC-34041-VPS VPS7220B VPS7220B VPS7220B VPS7220B  Batch Nos.: 23F14A1779 23F14D0281 23F14M0072 23F14D1271 23F14G0101 23F14G1295 23F14E1325 23F15A1407 23F14F0406 23F15B1012 23F14J0973 23F14G0091 23F15B1630 23F14F0782 RF3053214 23F14M0791 23F14K1260 RF3052236 23F14J1421 23F13M0751 23F13L0144 23F14L0635 RF3052644 23F14K1255 23F14D0332 23F14B1160 23F15B1628 RF3064510 23F14M0026 23F14G0107 23F14D0759 RF3042008 23F14A0375 23F14A1189 23F14J1433 23F14F1092 23F13M0589 23F14A1493 23F14B1128 23F15A0122 23F14G0916 23F14A0451 23F14B0740 23F14C0473 RF3053218 23F14H0046 23F14A1495 23F14B1120 23F14D0308 23F14A1277 23F14J1319 23F14B0056 23F14C0463 23F14J1391 23F14D0378 23F14K1292 23F14B0742 23F14D0286 23F14K1472 23F14F0284 23F15A1551 23F14D0282 23F14E1261 23F14A0448 23F14H0408 23F14K1060 23F14C0728 23F14E1469 23F14A1534 23F14K1258 23F15C1225 23F14H1312 23F14E1262 23F14B0744 23F15A0563 23F15C1226 23F14H0498 23F14G0096 23F14C0476 V1302008 23F14G1091 23F15A0120 23F14H0510 23F14D0314 19F13H0023 23F14J1134 23F15A1191 23F14H1254 23F14F0780 19F13H0022 23F14M1083 23F14A1207 23F14J1390 23F14F1273 19F13K0008 23F15E0418 23F14A1207 23F14K0677 23F14H0512 19F13K0007 23F14C0738 23F14D0284 23F14K1216 23F14K1473 19F13J0012 23F14H0301 23F14G0094 23F14K1243 23F14L0940 19F13K0006 23F14C0740 23F14H1313 23F14L0608 23F13K1266 19F13L0009 23F14F1347 RF3041482 23F14L0969 23F14A1267 19F13K0009 23F14H0885 23F14A1274 23F15A0347 23F14C0459 19F13K0005 23F15B1858 23F14B1144 23F14L0986 23F14D0322 19F13J0014 23F15B1861 23F14D0285 RF3015350 23F14F0782 19F13L0010 23F13L0293 23F14G0095 23F13K1165 23F14H1315 19F13J0013 23F14A1229 23F14H1314 23F13M0521 23F14M0696 19F13L0031 23F14B0752 23F14K1250 23F14C0452 23F14D0328 19F13K0018 19F13K0019 19F14D0007 19F14J0007 19F15A0017 19F13K0020 19F14D0015 19F14J0008 19F15B0007 19F13J0011 19F14E0008 19F14J0010 19F15B0008 19F13J0015 19F14D0018 19F14K0007 19F15C0005 19F13L0038 19F14D0019 19F14K0008 19F15C0007 19F13K0016 19F14E0013 19F14K0009 19F15C0015 19F13L0036 19F14E0005 19F14K0010 19F15C0014 19F13K0017 19F14E0006 19F14K0015 19F15C0006 19F13L0007 19F14F0006 19F14M0008 19F15C0008 19F13L0028 19F14F0007 19F14K0016 19F15C0017 19F13L0011 19F14F0008 19F14M0010 19F15C0016 19F13L0029 19F14F0009 19F14M0006 19F13L0037 19F14E0007 19F14L0005 19F13L0030 19F14E0014 19F14L0008 19F13M0009 19F14E0015 19F14M0007 19F13L0039 19F14E0016 19F14L0006 19F13M0006 19F14F0017 19F14L0007 19F13M0008 19F14H0005 19F14K0017 19F13M0007 19F14F0018 19F14K0018 19F14B0007 19F14F0020 19F15A0008 19F14B0012 19F14F0019 19F15A0007 19F14B0006 19F14H0006 19F15A0009 19F14B0008 19F14H0007 19F15A0019 19F14B0010 19F14H0008 19F14M0009 19F14C0003 19F14H0013 19F15A0016 19F14D0017 19F14H0014 19F15A0006 19F14D0008 19F14H0015 19F15A0018 19F14D0005 19F14H0016 19F15B0006 19F14D0016 19F14J0005 19F15B0005 19F14D0006 19F14J0006 19F15A0020
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide and Internationally to Canada.
  • Product Description
    Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
  • Manufacturer
  • Model / Serial
    Lot number RF2033361
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
  • Product Description
    Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A || The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
  • Manufacturer
  • Model / Serial
    Lot Number/Serial Numbers: MF7065606 MF7076012 MF7076021 MF7086462 MF7086736 MF7107536 MF7107537 MF7107694 MF7107696 MF7118048 MF7118049 MF7118050 MF7118151 MF7118221 MF7118222 MF7128472 MF7128506 MF7128507 MF8018908 MF8019033 MF8019034 MF8019035 MF8019104 MF8029191 MF8029433 MF8029434 MF8039774 MF8040251 MF8040287 MF8050764 MF8050812 MF8050966 MF8061267 MF8061413 MF8071676 MF8071863 MF8082268 MF8082507 MF8093002 MF8103280 MF8103416 MF8103571 MF8113836 MF8113919 MF8113951 and MF8124345.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
  • Product Description
    8 Fr 40cc Ultra 8 IAB, || IAB-05840-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
  • Manufacturer
  • Model / Serial
    Lot/Serial Numbers: MF6079580 MF6100954 MF7033668 MF7086558 MF7086984 MF7097225 MF7097426 MF7118000 MF7118001 MF7128557 and MF8018922.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
  • Product Description
    8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters || Product Number: IAB-04830-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
  • Manufacturer
  • Model / Serial
    Lot/ASerial Numbers: MF6090318 MF6111511 MF7065955 MF7076255 MF7086556 MF7097114 MF7097115 MF7097226 MF7097227 MF7097228 MF7097427 MF7097470 MF7097471 MF7107861 MF7107862 MF7118045 MF7118046 MF7128470 MF7128508 MF8018724 MF8018813 MF8018996 MF8124303 MF8124304  MF8124304 MF9014426 MF9014444 MF9014446 and MF9014447.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
  • Product Description
    8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters || Product Number: IAB-04840-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
  • Manufacturer
10 more