FDA recall Z-1172-2018

GETINGE US SALES LLC · Class II · device

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

Key facts

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2018