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-0892-04
• Recall Event ID: 28689
• 510(K)Number: K982215
• Product Classification: Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
• Product: STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
• Code Information: Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
• 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: 520 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