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U.S. Department of Health and Human Services

Class 2 Device Recall FastCath Hemostasis Introducer, HEMOSTASIS INTRODUCER

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 Class 2 Device Recall FastCath Hemostasis Introducer, HEMOSTASIS INTRODUCERsee related information
Date Initiated by FirmDecember 09, 2019
Create DateJanuary 08, 2020
Recall Status1 Terminated 3 on December 11, 2020
Recall NumberZ-0789-2020
Recall Event ID 84459
510(K)NumberK914090 
Product Classification Introducer, catheter - Product Code DYB
ProductFast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Code Information Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183  Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628  Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144
Recalling Firm/
Manufacturer		 Abbott Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information ContactAlicia Swanson
408-845-3427
Manufacturer Reason
for Recall		Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
FDA Determined
Cause 2		Packaging
ActionBeginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.
Quantity in Commerce380 devices
DistributionWorldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
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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