Z-2632-2017Class II

3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware...

Name: Z-2632-2017 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware...
Creator: 3M Company - Health Care Business
Published: 2017-05-22
License: https://open.fda.gov/license/

3M Company / initiated 2017-05-22 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 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... on 2017-05-22. FDA classified it as Class II and gives the reason as "It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2632-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-06-26
Terminated: 2018-06-14
Recalling firm: 3M Company
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.
Product code: KZD Infusor, Pressure, For I.V. Bags
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email [email protected] if you have any questions.
Quantity in commerce: 1 unit
Distribution: U.S. Distribution: TX only
Product codes and lots: Serial Number: 100873

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2632-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2632-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-26

Product code KZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)