The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven… — Class II medical device recall Z-2559-2019
Terminated recall by GETINGE US SALES LLC, reported 2019-10-02, distributed in NJ. Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOL
| Recall number | Z-2559-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, WAYNE, NJ, United States |
| Recall initiated | 2019-08-22 |
| Classified | 2019-09-23 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2020-04-27 |
| Distributed | NJ |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00384401018452 |
| Lot numbers | 18K31 |
| Serial numbers | 1190443415 |
| Model numbers | M00202166168P0 |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2559-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.