Recall Z-0336-2014 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Terumo Cardiovascular Systems Corporation
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
| Date | Nov 18, 2013 (initiated Oct 23, 2013) |
| Status | Terminated |
| Reason | 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 | Error in labeling |
| Action | 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. |
| Quantity | 9 |
| Distribution | US Distribution in the states of: NC and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990503 | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS Sulzermedica, Dec 9, 1999 |