Events

Recall of Device Recall Super ArrowFlex Percutaneous Sheath Introducer Sets

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
    73045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1064-2016
  • Event Initiated Date
    2016-01-12
  • 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=142906
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Arrow has issued a recall for these products due to potential packaging damage. the sterility of the products cannot be guaranteed. if non-sterile product is used there is a potential for infection to occur.
  • Action
    Arrow International sent an Urgent Medical Device Recall Notification letter dated January 13, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recall@telefex.com. A customer service representative will contact them with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to the firm. If customers have no affected stock, they should also complete and the enclosed Recall Acknowledgement Form. Customers with questions should call Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Device

Device Recall Super ArrowFlex Percutaneous Sheath Introducer Sets
  • Model / Serial
    Material number :CL-07035 Batch #'s: CF0045142 CF0087118 CF0090127 CF0128575 CF1022799 CF1034863 CF1046302 CF1060275 CF1083652 CF2019968 CF2021329 CF2045237 CF2056298 CF2092322 CF2125658 CF3031070 14F13G0157 14F13H0140 14F13K0108 14F13K0334 14F14A0435 14F14B0295 14F14C0449 14F14F0184 14F14F0282 14F14J0055 14F14L0126 14F15A0097 14F15A0473 14F15C0455 14F15C0455 14F15E0083 14F15E0392 14F15G0350 14F15L0009  Material #: CL-07635 Batch #'s: CF0014629 CF0016145 CF0026765 CF0027875 CF0029004 CF0031879 CF0043747 CF0044445 CF0045312 CF0046072 CF0057307 CF0058371 CF0058639 CF0059715 CF0060443 CF0061539 CF0062000 CF0062968 CF0074416 CF0074954 CF0086388 CF0088268 CF0098848 CF0099814 CF0090135 CF0090990 CF0104732 CF0115512 CF0115640 CF0117991 CF0128581 CF0129532 CF1022803 CF1022900 CF1023194 CF1035539 CF1046005 CF1046603 CF1057461 CF1058601 CF1069026 CF1069417 CF1071115 CF1071530 CF1082816 CF1083655 CF1084050 CF1094408 CF1095121 CF1095422 CF1106140 CF1106463 CF1106567 CF1106866 CF1117776 CF1118184 CF2010024 CF2010554 CF2011013 CF2021345 CF2021568 CF2022380 CF2032704 CF2033760 CF2044057 CF2044557 CF2044918 CF2055632 CF2055879 CF2067193 CF2067783 CF2068117 CF2078723 CF2079280 CF2079792 CF2079893 CF2080185 CF2080838 CF2081222 CF2114750 CF2115091 CF2125371 CF2125810 CF3016842 CF3017268 CF3017895 CF3018102 CF3028486 CF3028692 CF3029687 CF3030417 CF3031073 CF3041971 CF3064771 CF3065130 14F13G0058 14F13G0104 14F13G0229 14F13H0292 14F13H0421 14F13J0267 14F13K0066 14F13K0171 14F13L0012 14F13L0105 14F13M0040 14F14A0310 14F14A0420 14F14B0167 14F14B0309 14F14C0077 14F14C0191 14F14D0013 14F14D0155 14F14D0351 14F14D0373 14F14F0230 14F14F0284 14F14G0425 14F14H0028 14F14H0309 14F14J0021 14F14J0098 14F14J0336 14F14K0036 14F14K0099 14F14K0382 14F14L0352 14F14M0121 14F15A0234 14F15A0341 14F15B0076 14F15B0156 14F15B0372 14F15C0066 14F15D0009 14F15D0089 14F15D0183 14F15D0395 14F15E0180 14F15E0393 14F15F0177 14F15F0409 14F15G0052 14F15G0403 14F15H0237 14F15H0400 14F15H0442 14F15J0047 14F15J0128 14F15J0376 14F15K0480 14F15M0076  Material #: CL-07735 Batch #'s: CF0016456 CF0026767 CF0027385 CF0028486 CF0031869 CF0043766 CF0045145 CF0046070 CF0057960 CF0059633 CF0060473 CF0062110 CF0063321 CF0074956 CF0087127 CF0088323 CF0090136 CF0102551 CF0104733 CF0115515 CF0117962 CF0128881 CF1010273 CF1022804 CF1023188 CF1034955 CF1035534 CF1046237 CF1057122 CF1057847 CF1069027 CF1069422 CF1060281 CF1071533 CF1084052 CF1094634 CF1105903 CF1106857 CF1118176 CF1129218 CF2010449 CF2011017 CF2032701 CF2033764 CF2044055 CF2044562 CF2055623 CF2055885 CF2067195 CF2068127 CF2078858 CF2079277 CF2079801 CF2079894 CF2080840 CF2125806 CF3017886 CF3018109 CF3028509 CF3028705 CF3039881 CF3030420 CF3031076 CF3041472 CF3052851 CF3065365 14F13G0062 14F13H0125 14F13H0221 14F13H0412 14F13J0045 14F13J0151 14F14A0132 14F14A0423 14F14A0309 14F14B0416 14F14C0323 14F14E0190 14F14E0288 14F14F0064 14F14F0185 14F14F0295 14F14J0323 14F14K0041 14F14K0336 14F14M0038 14F14M0103 14F15A0237 14F15B0022 14F15B0297 14F15B0383 14F15D0382 14F15E0072 14F15F0178 14F15H0347 14F15J0269 14F15K0186 14F15K0481  Material #: CL-07835 Batch #'s: CF0014633 CF0026778 CF0028429 CF0029002 CF0043169 CF0046789 CF0058376 CF0061314 CF0062035 CF0063323 CF0086389 CF0098907 CF0090978 CF0104735 CF0128583 CF1022800 CF1023680 CF1035526 CF1046612 CF1057118 CF1058023 CF1069009 CF1069427 CF1071067 CF1082806 CF1084066 CF1094643 CF1095413 CF1106147 CF1117143 CF2010674 CF2021578 CF2022383 CF2033430 CF2044046 CF2055624 CF2056307 CF2056890 CF2067792 CF2068581 CF2079137 CF2079794 CF2079908 CF2080524 CF3016368 CF3016852 CF3018112 CF3028508 CF3029318 CF3039885 CF3031078 CF3041826 CF3042524 CF3053165 CF3065135 14F13G0155 14F13H0127 14F13H0288 14F13J0038 14F13K0175 14F13L0070 14F13L0243 14F13M0045 14F14A0428 14F14B0161 14F14B0305 14F14C0105 14F14D0055 14F14F0116 14F14F0287 14F14G0466 14F14J0022 14F14J0326 14F14K0280 14F14L0068 14F15A0334 14F15A0334 14F15B0230 14F15B0367 14F15C0185 14F15F0282 14F15G0159 14F15G0470 14F15H0402 14F15K0482 14F15M0243
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL AR AZ CA CO CT DE FL GA IA ID IL IN KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV
  • Product Description
    Super Arrow-Flex Percutaneous Sheath Introducer Sets || REF CL-07035 or CL-07635 or CL-07735 or CL-07835 || Super Arrow-Flex || Percutaneous Sheath Introducer Set || with Integral Hemostasis Valve/Side Port || and Radiopaque Tip Marker Band || Contents: || 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque || with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator || 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. || Rx only. || The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
  • 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