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U.S. Department of Health and Human Services

Class 2 Device Recall FastCath Trio HEMOSTASIS INTRODUCER

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 Class 2 Device Recall FastCath Trio HEMOSTASIS INTRODUCERsee related information
Date Initiated by FirmDecember 09, 2019
Create DateJanuary 07, 2020
Recall Status1 Terminated 3 on December 14, 2020
Recall NumberZ-0783-2020
Recall Event ID 84454
510(K)NumberK954317 
Product Classification Introducer, catheter - Product Code DYB
ProductFast-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
For Additional Information ContactMr. 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
ActionBeginning 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 Commerce814 devices
DistributionWorldwide 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DYB
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