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Terminated

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.

FDA Recall Z-2632-2017 · Posted None

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeKZD
Date Initiated2017-05-22
Date Terminated2018-06-14
Product Quantity1 unit

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

U.S. Distribution: TX only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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