# FDA recall Z-1172-2018

> **GETINGE US SALES LLC** · Class II · device recall initiated 2018-01-03.

## Product

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

## Reason for recall

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

## Distribution

FL

## Key facts

- **Recall number:** Z-1172-2018
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-03
- **Report date:** 2018-04-04
- **Termination date:** 2018-07-03

- **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-1172-2018

## Citation

> AI Analytics. FDA recall Z-1172-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-1172-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*