FDA recall Z-2632-2017

3M Company - Health Care Business · Class II · device

Product

3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

Reason for recall

It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.

Distribution

U.S. Distribution: TX only

Key facts

Status
Terminated
Initiation date
2017-05-22
Report date
2017-07-05
Termination date
2018-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2632-2017