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U.S. Department of Health and Human Services

Class 1 Device Recall Giraffe and Panda Warmer TPiece Resuscitation System

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 Class 1 Recall
Giraffe and Panda Warmer TPiece Resuscitation System
see related information
Date Posted December 26, 2012
Recall Status1 Terminated on April 14, 2014
Recall Number Z-0606-2013
Recall Event ID 63123
Premarket Notification
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, Wisconsin 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BTL and Original Applicant = OHMEDA MEDICAL
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