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Recall Observatory FDA recall evidence

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.

Z-2632-2017

May 22, 2017

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 77399
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2632-2017

Official wording

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

Code information: Serial Number: 100873

Distribution pattern: U.S. Distribution: TX only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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