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U.S. Department of Health and Human Services

Class 2 Device Recall STATCheck

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  Class 2 Device Recall STATCheck see related information
Date Initiated by Firm March 15, 2016
Date Posted June 01, 2016
Recall Status1 Terminated 3 on November 01, 2016
Recall Number Z-1880-2016
Recall Event ID 73766
510(K)Number K982215  K093525  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product STAT-Check Resuscitation Bag
Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer
Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
Code Information Model SC9001B Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot numbers 303320 and 303612  Model SC9001C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask Lot number 303400  Model SC9001C-C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector Lot numbers 303523 and 303791  Model SC8001B Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot number 303833    
Recalling Firm/
Manufacturer		 Ventlab LLC
2710 Northridge Dr NW Ste A
Grand Rapids MI 49544-9112
For Additional Information Contact Rob Yamashita
844-635-5326
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 2430
Distribution Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
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.
510(K) Database 510(K)s with Product Code = CCK and Original Applicant = MEDICAL MARKETING CONCEPTS
510(K)s with Product Code = CCK and Original Applicant = VENTLAB CORP.
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