Medical device recalls Moderate risk

Maquet recalls Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation du…

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0490-2018
FDA classification
Class II
Brand / firm
Maquet
Sold / distributed
Distributed to the states of NM, CA, and IL.

Why it was recalled

55 kits were distributed after their expiration date of September 2015.

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

What was recalled

Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.

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