Z-2559-2019Class II

The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft...

Name: Z-2559-2019 The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft...
Creator: Getinge US Sales Llc
Published: 2019-08-22
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2019-08-22 / Terminated / root cause: labeling and UDI

FDA source

GETINGE US SALES LLC began a recall of The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The... on 2019-08-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2559-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-22
Posted: 2019-09-24
Terminated: 2020-04-27
Recalling firm: Getinge US Sales LLC
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 collagen, the graft also contains glycerol as a softening agent.
Product code: MAL Graft, Vascular, Synthetic/Biologic Composite
Reason for recall: 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 tag: labeling and UDI
FDA 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, 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)
Quantity in commerce: 1 unit
Distribution: US state of NJ
Product codes and lots: Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2559-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2559-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code MAL

K021213Class IIModification to Hemashield Platinum Woven/microvel Double Velour Vascular GraftsBoston Scientific Corp / cleared 2002-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)