Z-2542-2021Class II

The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem...

Name: Z-2542-2021 The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem...
Creator: Vascutek, Ltd.
Published: 2021-07-08
License: https://open.fda.gov/license/

Vascutek, Ltd. / initiated 2021-07-08 / Terminated / root cause: labeling and UDI

FDA source

Vascutek, Ltd. began a recall of The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave... on 2021-07-08. FDA classified it as Class II and gives the reason as "The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2542-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-08
Posted: 2021-09-24
Terminated: 2024-08-19
Recalling firm: Vascutek, Ltd.
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
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 159 total vascular grafts and patches
Distribution: Distribution was made to PR and Guam.
Product codes and lots: To be reported.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2543-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code DSY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)