GETINGE US SALES LLC: Medical Device Recall in 2018 - (Recall #: Z-1172-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Product Classification:

Class II

Date Initiated: January 3, 2018

Date Posted: April 4, 2018

Recall Number: Z-1172-2018

Event ID: 79536

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).

Status: Terminated

Product Quantity: 1

Code Information:

UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated