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Terminated

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

FDA Recall Z-2543-2021 · Posted None

Recalling FirmVascutek, Ltd.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2021-07-08
Date Terminated2024-08-19
Product Quantity159 total vascular grafts and patches

Reason for Recall

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Firm Action

The recalling firm sent emails on 7/8/2021 to the two distributors that contained the Field Safety Notice and the correct IFU to be supplied with products distributed to the United States.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution was made to PR and Guam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972201PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENESulzer Carbomedics, Inc. · 1998-04-14K963611VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCHVascutek, Ltd. · 1996-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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