Class 1 Device Recall Ventlab Manual Resuscitators

• Date Initiated by Firm: May 16, 2014
• Date Posted: July 03, 2014
• Recall Status: Terminated on November 17, 2015
• Recall Number: Z-1948-2014
• Recall Event ID: 68242
• 510(K)Number: K953546 K982215 K012842
• Product Classification: Ventilator, emergency, manual (resuscitator) - Product Code BTM
• Product: Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.
• Code Information: Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.
• Recalling Firm/ Manufacturer: Ventlab LLC; 2710 Northridge Dr Nw; Suite A; Grand Rapids MI 49544-9112
• For Additional Information Contact: 800-237-5481
• Manufacturer Reason for Recall: The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
• FDA Determined Cause: Process change control
• Action: The firm, Ventlab, issued a press dated May 14, 2014, stating Ventlab, LLC has initiated a voluntary medical device removal of a limited number of Ventlab" Resuscitator Bags. The bag series and lot numbers were included in a table as well as manufacture dates. In addition, Ventlab, LLC sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 19, 2014 to its distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to review and examine their inventory for affected product; stop using them and immediately contact Ventlab, LLC for further instructions on the return of these products; and if product was further distributed, identify their customers/consignees and notify them of this product removal. The customers were also instructed to complete and return the attached Return Response Form via fax at 1-800-400-8820, Attn: Quality Department, or email to: PFA@ventlab.com as soon as possible and inform all affected personnel of this removal. Ventlab will send new corrected replacement resuscitation bags to customers once you return the affected product. If you have any questions regarding this action, please call Ventlab at 1-800-237-5481 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday, or 1-844-635-5326 or via e-mail at PFA@ventlab.com.
• Quantity in Commerce: 251,384
• Distribution: US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
• 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 and Original Applicant = MEDICAL MARKETING CONCEPTS; 510(K)s with Product Code = BTM and Original Applicant = VENTLAB CORP.