FDAJune 19, 2023device
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
00844735006148515600000011
Recall history
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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