| Class 2 Device Recall FastCath Trio HEMOSTASIS INTRODUCER | |
Date Initiated by Firm | December 09, 2019 |
Create Date | January 07, 2020 |
Recall Status1 |
Terminated 3 on December 14, 2020 |
Recall Number | Z-0783-2020 |
Recall Event ID |
84454 |
510(K)Number | K954317 |
Product Classification |
Introducer, catheter - Product Code DYB
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Product | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 |
Code Information |
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555 |
Recalling Firm/ Manufacturer |
Abbott Medical 5050 Nathan Ln N Plymouth MN 55442-3209
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For Additional Information Contact | Mr. Justin Paquette 651-756-6293 |
Manufacturer Reason for Recall | Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. |
FDA Determined Cause 2 | Packaging |
Action | Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1). |
Quantity in Commerce | 814 devices |
Distribution | Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay |
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 = DYB
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