Recall Z-1172-2018— GETINGE US SALES LLC

Name: FDA recall Z-1172-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-03

Class II · Terminated

Class II FDA medical device recall by GETINGE US SALES LLC, initiated 2018-01-03, terminated 2018-07-03. It names one FDA 510(k) clearance: K955349. Product: HEMASHIELD Knitted Double Velour Cardiovascular Fabric. Reason: 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)..

Recalling firm: GETINGE US SALES LLC
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Terminated: 2018-07-03
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K955349 — HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICMeadox Medicals, Div. Boston Scientific Corp.·cleared 1996-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.