Fast-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.
FDA Recall Z-0789-2020 · Posted None
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Recalling FirmAbbott Medical
Recall StatusTerminated
Product CodeDYB
Date Initiated2019-12-09
Date Terminated2020-12-11
Product Quantity380 devices
Reason for Recall
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Firm Action
Beginning 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.
Root Cause
Packaging
Distribution Pattern
Worldwide 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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