FDA Device Recall Z-0789-2020: Abbott Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0789-2020.

Recall Res Number

Z-0789-2020

Recalling Firm / Manufacturer

Abbott Medical

FEI Number

3005334138

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-12-09

Date Posted

N/A

Date Terminated

2020-12-11

Product Code

DYB

Event Number

84459

Product Quantity

380 devices

Product Description 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.

Reason for Recall Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

Action Details 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.

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

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0789-2020

Recall Parameters & Description

Related Establishments / Registrations

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