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U.S. Department of Health and Human Services

Class 2 Device Recall VORTRAN Automatic Resuscitator, VARPlus

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  Class 2 Device Recall VORTRAN Automatic Resuscitator, VARPlus see related information
Date Initiated by Firm April 20, 2017
Date Posted April 25, 2017
Recall Status1 Terminated 3 on October 17, 2017
Recall Number Z-2092-2017
Recall Event ID 77072
510(K)Number K973975  K001430  K041473  
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
Product VORTRAN Automatic Resuscitator, VARPlus with Extension Kit;
Model PCE-5012; Qty: 10 each.

Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory
support.
Code Information Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04. 
Recalling Firm/
Manufacturer		 Vortran Medical Technology 1, Inc
21 Goldenland Court Ste 100
Sacramento CA 95834-2427
For Additional Information Contact James Lee
800-434-4034 Ext. 15
Manufacturer Reason
for Recall		 Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
FDA Determined
Cause 2		 Process control
Action Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.
Quantity in Commerce 14 cases (10 each)
Distribution CA, MS, FL
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 = BTL and Original Applicant = VORTRAN MEDICAL TECHNOLOGY 1, INC.
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