FDAOctober 6, 2017device
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
What to do
FDA enforcement status: Terminated
Brands named
baxter healthcarebaxter
UPCs
00085412091570
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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