STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in var

FDA device recall Z-1880-2016 · posted 2016-06-01 · Terminated

Recall details

Recalling firm

Ventlab LLC

Reason for recall

Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

Action taken

Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 2016, on March 15, 2016, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at PFA@ventlab.com.

Root cause

Process control

Status

Terminated

Product code

CCK

Quantity affected

2430

Distribution

Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.

Date initiated

2016-03-15

Date posted

2016-06-01

Date terminated

2016-11-01

Location

Grand Rapids, MI

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