# FDA recall Z-2559-2019

> **GETINGE US SALES LLC** · Class II · device recall initiated 2019-08-22.

## 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).

## Distribution

US state of NJ

## Key facts

- **Recall number:** Z-2559-2019
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-22
- **Report date:** 2019-10-02
- **Termination date:** 2020-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** WAYNE, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2559-2019

## Citation

> AI Analytics. FDA recall Z-2559-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2559-2019. Source: US FDA. Licensed CC0.

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