Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Adult Resuscitator, Pro5000 Series

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Adult Resuscitator, Pro5000 Seriessee related information
Date Initiated by FirmJuly 11, 2012
Date PostedNovember 01, 2012
Recall Status1 Terminated 3 on June 30, 2013
Recall NumberZ-0171-2013
Recall Event ID 63347
510(K)NumberK012842 
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
ProductAdult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code Information Product List 071012, Product Code: PRO-5009P, Lot #102217.
Recalling Firm/
Manufacturer		 Ventlab Corporation
155 Boyce Dr
Mocksville NC 27028-4187
For Additional Information ContactJames A. Cochie
336-753-5000
Manufacturer Reason
for Recall		Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
FDA Determined
Cause 2		Component design/selection
ActionVentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
Quantity in Commerce14,602 total for all units
DistributionNationwide Distribution including IL, OH, NY and TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BTM
-
-