CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respirator

FDA device recall Z-2593-2014 · posted 2014-09-19 · Terminated

Recall details

Recalling firm

CareFusion 203, Inc.

Reason for recall

CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre

Action taken

CareFusion sent a Product Recall Notice dated August 8, 2014, to all affected customers. The letter listed the product involved in the recall, described the Issue, Potential Risk , Actions to be Taken by Carefusion, Action to be Taken by the Customer and Other information. Customers were not required to return the devices. Customers were asked to perform the following actions: Once the kit(s) has/have been received, these kits must be fitted and a confirmation must be returned to CareFusion for each kit fitted, identifying the ventilator serial numbers and/or number of AC Power Adapters, Auto Lighter Power Cords to which the kit has been fitted. The confirmation card will be in each kit. To avoid possible delays in providing ventilation and for future compatibility, customers must update their entire inventory. Warranty is void if vent-side LEMO adapter is not properly used in accordance with its instructions and ventilator is damaged due to misuse. Contact Information: CareFusion Support Center, SupportCenter@CareFusion.com Phone 1-888-562-6018, Fax 1-858-617-4851 (Monday through Friday 7AM to 4PM Pacific); Customer Service & Technical Support, ACVentCare@CareFusion.com, Phone: 1-800-754-1914; FAX CS: 1-763-398-8403 (24 hours and 7 days a week between the hours of CST 8:00 am - 5:00pm. After hours and on weekends expect a one hour call back. For questions regarding this recall call 888-562-6018.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

1729

Distribution

Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI.

Date initiated

2014-08-08

Date posted

2014-09-19

Date terminated

2015-10-07

Location

Minneapolis, MN

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