Class 2 Device Recall STATCheck

• Date Initiated by Firm: March 26, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 07, 2004
• Recall Number: Z-0891-04
• Recall Event ID: 28689
• 510(K)Number: K982215
• Product Classification: Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
• Product: STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
• Code Information: Model #SC9000B, Lot #4034-10, 4047-07, 4064-10; Model #SC9000C, Lot #3295-03; Model #SC9001B, Lot #3290-03, 3309-22, 4047-05, 4064-11, 4071-13; Model #SC9001C, Lot #3290-04,3309-24, 3349-05, 4034-04.
• Recalling Firm/ Manufacturer: Ventlab Corporation; 155 Boyce Dr; Mocksville NC 27028
• For Additional Information Contact: Robert M. Kelly; 336-492-2636
• Manufacturer Reason for Recall: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 3/26/2004.
• Quantity in Commerce: 3070 units
• Distribution: 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 = BTM