Recall Z-2559-2019 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
GETINGE US SALES LLC
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed b
| Date | Aug 22, 2019 |
| Status | Terminated |
| Reason | Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm). |
| Root cause | Under Investigation by firm |
| Action | 1. Please examine your inventory immediately to determine if you have the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product. 2. Please remove the affected product from areas of use. 3. Affected product should be returned to Getinge per the following process: Please complete the Urgent Medical Device Recall Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall Removal letter. Please fax or email the completed form to Getinge office as instructed on the form. Please contact Getinge Customer Service at 18886278383 (press option 2, the |
| Quantity | 1 unit |
| Distribution | US state of NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS Boston Scientific Corp, Apr 19, 2002 |