| | Class 3 Device Recall Cordis Vista Brite Tip
AdroitTM Guiding Catheter |  |
| Date Initiated by Firm | February 07, 2019 |
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| Create Date | April 18, 2019 |
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| Recall Status1 |
Terminated 3 on November 03, 2021 |
| Recall Number | Z-1198-2019 |
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| Recall Event ID |
82481 |
| 510(K)Number | K021593 K143412 K963962 K972978 K992673 |
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| Product Classification |
Catheter, percutaneous - Product Code DQY
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| Product | Cordis Vista Brite Tip & Androit Guiding Catheters
Product Usage:
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. |
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| Code Information |
Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 17735534 10/31/2020 17744429 12/31/2020 17744430 12/31/2020 17750785 12/31/2020 17757116 1/31/2021 17748743 12/31/2020 17750476 12/31/2020 17755096 1/31/2021 17757122 1/31/2021 17753002 12/31/2020 17779364 4/30/2021 17815946 9/30/2021 17805148 7/31/2021 17815949 9/30/2021 17753959 1/31/2021 17746022 12/31/2020 17762925 2/28/2021 17733016 10/31/2020 17747583 12/31/2020 17749800 12/31/2020 17752698 12/31/2020 17767925 2/28/2021 17769354 3/31/2021 17771053 3/31/2021 17772929 4/30/2021 17722360 9/30/2020 17735189 10/31/2020 17733019 10/31/2020 17746026 12/31/2020 17747584 12/31/2020 17749793 12/31/2020 17752703 12/31/2020 17754875 1/31/2021 17756762 1/31/2021 17762928 2/28/2021 17771058 3/31/2021 17772931 4/30/2021 17816029 9/30/2021 17817637 9/30/2021 17722359 9/30/2020 17740611 11/30/2020 17778655 4/30/2021 17724480 9/30/2020 17767923 2/28/2021 17771049 3/31/2021 17772926 4/30/2021 17756076 7/31/2020 17816499 3/31/2021 17753948 7/31/2020 17777712 10/31/2020 17816501 3/31/2021 17729208 3/31/2020 17733005 4/30/2020 17736643 4/30/2020 17737608 4/30/2020 17740605 5/31/2020 17742559 5/30/2020 17743099 6/30/2020 17743101 6/30/2020 17745965 6/30/2020 17756074 7/31/2020 17816500 3/31/2021 17756075 7/31/2020 17746147 12/31/2020 17807995 8/31/2021 17811028 8/31/2021 17814511 9/30/2021 17818155 9/30/2021 17755015 1/31/2021 17724819 9/30/2020 17742581 11/30/2020 17756975 1/31/2021 17771328 3/31/2021 17794750 6/30/2021 17814264 9/30/2021 17816167 9/30/2021 17750494 12/31/2020 17817649 9/30/2021 17800760 7/31/2021 17801566 7/31/2021 17802170 7/31/2021 17802171 7/31/2021 17803141 7/31/2021 17803142 7/31/2021 17803143 7/31/2021 17803536 7/31/2021 17803539 7/31/2021 17803540 7/31/2021 17804225 7/31/2021 17804226 7/31/2021 17804764 7/31/2021 17805447 7/31/2021 17805899 8/31/2021 17805901 8/31/2021 17806219 8/31/2021 17806330 8/31/2021 17806331 8/31/2021 17806332 8/31/2021 17806706 8/31/2021 17807595 8/31/2021 17807603 8/31/2021 17807626 8/31/2021 17807628 8/31/2021 17807629 8/31/2021 17809536 8/31/2021 17809537 8/31/2021 17809538 8/31/2021 17809786 8/31/2021 17809791 8/31/2021 17809792 8/31/2021 17809793 8/31/2021 17810429 8/31/2021 17810430 8/31/2021 17810432 8/31/2021 17810433 8/31/2021 17811219 8/31/2021 17811220 8/31/2021 17811221 8/31/2021 17811677 8/31/2021 17811834 8/31/2021 17811836 8/31/2021 17811837 8/31/2021 17811839 8/31/2021 17812321 8/31/2021 17813158 9/30/2021 17813159 9/30/2021 17814278 9/30/2021 17814279 9/30/2021 17814640 9/30/2021 17814641 9/30/2021 17814642 9/30/2021 17814643 9/30/2021 17815025 9/30/2021 17815340 9/30/2021 17817001 9/30/2021 17817002 9/30/2021 17817004 9/30/2021 17817285 9/30/2021 17818563 9/30/2021 17818564 9/30/2021 17819221 9/30/2021 17819222 9/30/2021 17821534 10/31/2021 17800613 7/31/2021 17800614 7/31/2021 17800615 7/31/2021 17802172 7/31/2021 17803537 7/31/2021 17803538 7/31/2021 17804026 7/31/2021 17804222 7/31/2021 17804223 7/31/2021 17804224 7/31/2021 17804765 7/31/2021 17804766 7/31/2021 17805898 7/31/2021 17805900 8/31/2021 17805902 8/31/2021 17806214 8/31/2021 17807627 8/31/2021 17808004 8/31/2021 17809486 8/31/2021 17811835 8/31/2021 17815021 9/30/2021 17815022 9/30/2021 17815023 9/30/2021 17815024 9/30/2021 17817003 9/30/2021 17819220 9/30/2021 |
Recalling Firm/
Manufacturer |
Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
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| For Additional Information Contact |
786-313-2000 |
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Manufacturer Reason
for Recall | Frayed pieces of the mounting card being inside the primary packaging. |
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FDA Determined
Cause 2 | Equipment maintenance |
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| Action | A letter and Acknowledgement Form will be sent overnight on February 07, 2019 to the direct consignees.
The letter provides instructions to our direct consignees to notify any additional consignees or departments as to the market action.
For health care professionals with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235, Monday through Friday from 9:00 AM to 5:00 PM EST.
For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at:
GMB-FieldCorrectiveAction@cardinalhealth.com or call 1(800)292-9332 |
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| Quantity in Commerce | 23481 |
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| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam
Singapore and Canada |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DQY
510(K)s with Product Code = DQY
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