Bayer Healthcare recalls PET Infusion Pump

Recall date

September 30, 2016

Source

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

Recall number

Z-0400-2017

FDA classification

Class II

Brand / firm

Bayer Healthcare

Sold / distributed

Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United K…

Why it was recalled

The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.

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

What was recalled

PET Infusion Pump