Events

Recall of Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit

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
    70313
  • Event Risk Class
    Class 3
  • Event Number
    Z-1030-2015
  • Event Initiated Date
    2015-01-09
  • Event Date Posted
    2015-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132965
  • 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
    Certain product codes and lot numbers of kits with biopatch dressing were packaged with the incorrect size biopatch dressing. no risk to patients is anticipated.
  • Action
    Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.

Device

Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Cath...
  • Model / Serial
    Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS,   ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A,   ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A ,   CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and PR.
  • Product Description
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
  • Manufacturer
    Arrow International Inc

Manufacturer

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