Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Pr
FDA device recall Z-0336-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 9
- Distribution
- US Distribution in the states of: NC and CA.
- Date initiated
- 2013-10-23
- Date posted
- 2013-11-18
- Date terminated
- 2014-02-27
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS (K990503) | Sulzermedica | 1999-12-09 |