—#122925

Product

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

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K990503
Affected lot / code info: Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

Terumo CVS called affected consignees (via telephone)on 10/23/2013 of this device removal. Terumo CVS advised users to discontinue use and return all affected grafts in inventory. Terumo will replace or issue credit for returned grafts. Terumo provided consignees with the reason of the removal, potential hazard, and description of affected product. Terumo addressed any questions from the consignees. Consignees with questions were instructed to contact Terumo CVS Customer Service at 800-521-2818. For questions regarding this recall call 734-741-6173.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: US Distribution in the states of: NC and CA.

Timeline

Recall initiated: 2013-10-23
Posted by FDA: 2013-11-18
Terminated: 2014-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122925. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.