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U.S. Department of Health and Human Services

Class 3 Device Recall VCARE

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  Class 3 Device Recall VCARE see related information
Date Initiated by Firm April 15, 2003
Date Posted July 08, 2003
Recall Status1 Terminated 3 on August 07, 2003
Recall Number Z-0982-03
Recall Event ID 26369
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product V*CARE, Infant Resuscitator, with 40 cm H¿O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
Code Information Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB
Recalling Firm/
Manufacturer		 Ventlab Corporation
2934 Hwy 601 North
Mocksville NC 27028
For Additional Information Contact Robert M. Kelly
336-492-2636
Manufacturer Reason
for Recall		 Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
FDA Determined
Cause 2		 Other
Action Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.
Quantity in Commerce 9 cases (10 units per case)
Distribution The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
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.
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