Venous Hardshell Cardiotomy Reservoir recalled over sterility concerns

Recall date

May 18, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Maquet Medical Systems USA recalls Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO…

Recall number

Z-1642-2023

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Domestic distribution nationwide.

Why it was recalled

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445