Class 2 Device Recall 3M Ranger(TM) Pressure Infusor, Model 145

• Date Initiated by Firm: May 22, 2017
• Create Date: June 26, 2017
• Recall Status: Terminated on June 14, 2018
• Recall Number: Z-2632-2017
• Recall Event ID: 77399
• Product Classification: Infusor, pressure, for i.V. Bags - Product Code KZD
• 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.
• Code Information: Serial Number: 100873
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave , B# 275-5-W-6; Saint Paul MN 55144-0001
• Manufacturer 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.
• FDA Determined 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 baprestera@mmm.com if you have any questions.
• Quantity in Commerce: 1 unit
• Distribution: U.S. Distribution: TX only
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.