Reported Nov 23, 2016 · Terminated
PET Infusion Pump
Bayer Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- PET Infusion Pump
- Lot codes and dates
- Impacted Batch Numbers
196 of 196 codes
20044840123020110777201107782012905320130260201430292016804320168044202184992022355420226461202290695037823050508655505144205051505550515057505628335056283450562835505628365057248150574207505742085057420950585611505861055059660550597703505978505060043550601580506025725060478550606331506200775062943750632873506342135065718150663447506650865066988150677540506861545068872450693453506951895069654050696563506986515069974150699882506998835070539750705398507182055071875650720431
- Impacted Batch Numbers
- Amount recalled
- 165,127 (79,714 units in U.S.)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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