FDAFDA · Food and drugs·Recall number Z-0336-2014
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries
Published November 27, 2013 · Recall initiated: October 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- US Distribution in the states of: NC and CA.
- Lot
- Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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