# FDA recall Z-2542-2021

> **Vascutek, Ltd.** · Class II · device recall initiated 2021-07-08.

## Product

The Instructions for Use (IFU) for:  Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts:      (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile.    (2) Vascutek Terumo Gelsoft  Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile.    (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile.    (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile.    (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile

## Reason for recall

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

## Distribution

Distribution was made to PR and Guam.

## Key facts

- **Recall number:** Z-2542-2021
- **Recalling firm:** Vascutek, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-08
- **Report date:** 2021-10-06
- **Termination date:** 2024-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Inchinnan, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2542-2021

## Citation

> AI Analytics. FDA recall Z-2542-2021. Retrieved 2026-09-15 from https://api.ai-analytics.org/recall/Z-2542-2021. Source: US FDA. Licensed CC0.

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