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 by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to colla Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to colla
Brand
GETINGE US SALES LLC
Lot Codes / Batch Numbers
Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452
Products Sold
Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452
GETINGE US SALES LLC is recalling The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft due to Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascula. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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, then option 5) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 5), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NJ
Page updated: Jan 10, 2026