Events

Recall of Device Recall Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71855
  • Event Risk Class
    Class 2
  • Event Number
    Z-2489-2015
  • Event Initiated Date
    2015-07-30
  • Event Date Posted
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139228
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, ultrasound, intravascular - Product Code OBJ
  • Reason
    Saline leakage from unsecured connections between the touhy borst adaptor and the hub of the catheter. no injuries reported.
  • Action
    Arrow International sent an Urgent Medical Device Recall Notification letter dated July 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Device

Device Recall Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component
  • 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
    Cardiovascular Devices
  • 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
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA