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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall 3M Ranger(TM) Pressure Infusor, Model 145 see related information
Date Initiated by Firm May 22, 2017
Create Date June 26, 2017
Recall Status1 Terminated 3 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 2
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.
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