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HUDSON RCI

TELEFLEX INCORPORATED · Model IPN914338 · UDI-DI 14026704656223

BZR Prescription
10
510(k) clearances
590
Adverse events (9 deaths)
3
Recalls
40
Facilities

Description

0.5 - Liter Latex Protein Free Hyperinflation Bag with Oxygen and Pressure Monitoring Tubing

Recalls

DateFirmReason
2018-05-15CAREstream Medical LLCTwo analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
2018-05-14O-Two Medical Technologies, Inc.Higher levels of nitrous oxide delivered than specification
2005-01-11Maquet IncSoftware update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.