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# CME America Updates Recalled BodyGuard Tests
- URL: https://www.fdaweb.com/cme-america-updates-recalled-bodyguard-tests/
- Published: 2020-07-15T12:00:00.000Z
- Updated: 2026-09-14T16:21:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147201

FDA says that as part of a CME America 4/27 recall of BodyGuard infusion system administration sets used with the company’s BodyGuard infusion pumps, the company conducted additional flow-rate accuracy testing. “The testing revealed that some infusion sets do not meet the ± 5% delivery accuracy for the system or the ± 13% accuracy identified in the earlier recall notification,” an FDA notice [says](http://s2027422842.t.en25.com/e/es?s=2027422842&e=352080&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=992df6dfc3834c289bd58ff1bc451f3a&elqaid=13361&elqat=1&ref=fdaweb.com). “Therefore the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.”