Class 1 Device Recall Various Drger Breathing Circuits/Anesthesia Sets

• Date Initiated by Firm: December 21, 2018
• Date Posted: January 24, 2019
• Recall Status: Terminated on April 16, 2019
• Recall Number: Z-0742-2019
• Recall Event ID: 81874
• Product Classification: Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFP
• Product: ID Circuit Watertrap (P) 180, Catalog Number MP01341; ; Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Michael A. Kelhart; 800-437-2437
• Manufacturer Reason for Recall: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
• FDA Determined Cause: Process design
• Action: On Friday 12/21/2018, Draeger, Inc. issued an "Urgent Medical Device Recall Notification" and Customer Reply and Order Form to consignees via Certified Mail. Two Recall Notifications/Customer Reply and Order forms will be sent to each facility. One will be addressed to Risk Manager. The other will be addressed to Purchasing/Materials Manager. Based on customer response, Draeger will replace any affected Breathing Circuits/Anesthesia Sets Free of Charge. Customers are advised to take the following action: - Before each use, and also after any temporary disconnection, please check whether the breathing circuit is assembled such that both the inspiratory and the expiratory connector of the ventilator or anesthesia machine are each connected to the y-piece. - Please inspect your existing stock by following the inspection instructions in the attachment and complete and return the attached Customer Reply and Order form via fax to:215-372-2940 or email to:denise.frey@draeger.com to confirm to us that you have carried out the inspections. The form is also used to order Free of Charge replacements if you find any breathing circuits that have been incorrectly pre-assembled. - The correct set-up of the breathing circuit is illustrated in the Instructions for Use not only of the hose systems but also of the anesthesia machines and ventilators. Connection to the device must be checked prior to use. An incorrectly pre-assembled breathing circuit can be detected because it will not be a single cohesive hose system but two separate sub-systems. Customers with questions, please call 1-800-437-2437 (press 1 at the prompt, then 32349).between the hours of 8:00 AM  4:30 PM EST.
• Quantity in Commerce: 25 units
• Distribution: US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
• 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.