Class 1 Device Recall Giraffe and Panda Warmer TPiece Resuscitation System

• Date Initiated by Firm: June 26, 2012
• Date Posted: December 26, 2012
• Recall Status: Terminated on April 14, 2014
• Recall Number: Z-0606-2013
• Recall Event ID: 63123
• 510(K)Number: K070210
• Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL
• Product: GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA***; ; Provides the basic equipment required for pulmonary resuscitation of infants.
• Code Information: 7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: Gwen Braeger; 262-513-4122
• Manufacturer Reason for Recall: Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: GE Healthcare sent an Urgent Medical Device Correction letter, dated June 26, 2012, with a return receipt to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction. Required Action for Users: Inspect existing stock of T-piece circuits to look for the Red inspection stamp, the T-pieces with the blue stamp are acceptable for clinical use. Separate affected circuits (with Red inspection stamp) from unaffected stock (with Blue inspection stamp). Destroy affected circuits that have the Red inspection stamp. Fill out the customer acknowledgement form and fax or forward to the GE contact address on the form. Further, it is recommended that healthcare professionals continue to emphasize the recommended pre-use checkout practices, and do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/- 5 cmH20. Clinicians should always use the built-in Airway Pressure Manometer to verify the PIP value. For questions or concerns regarding this notification, customers should call the following phone number: 1-800-345-2700.
• Quantity in Commerce: 209,804 circuits
• Distribution: Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates,
• 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 = BTL and Original Applicant = OHMEDA MEDICAL