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U.S. Department of Health and Human Services

Class 2 Device Recall Mercury Medical NeoTee

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  Class 2 Device Recall Mercury Medical NeoTee see related information
Date Initiated by Firm October 22, 2015
Create Date January 12, 2016
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-0639-2016
Recall Event ID 72540
510(K)Number K093913  
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
Product Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit.
The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
Code Information Neo-Tee Resuscitator: Part # 1050800 Unique Device ID # 10641043508004 Lot #s less than 1528850800; Part # 1050801 Unique Device ID # 10641043508015 Lot #s less than 1528850801;Part # 1050802 Unique Device ID # 10641043508022 Lot #s less than 1528850802; Part # 1050803 Unique Device ID # 10641043508039 Lot #s less than 1528850803; Part # 1050804 Unique Device ID # 10641043508046 Lot #s less than 1528850804; Part # 1050805 Unique Device ID # 10641043508053 Lot #s less than 1528850805; Part # 1050806 Unique Device ID # 10641043508060 Lot #s less than 1528850806; Part # 1050807 Unique Device ID # 10641043508077 Lot #s less than 1528850807; Part # 1050808 Unique Device ID # 10641043508084 Lot #s less than 1528850808; Part # 1050809 Unique Device ID # 10641043508091 Lot #s less than 1528850809; Part # 1050810 Unique Device ID # 10641043508107 Lot #s less than 1528850810; Part # 1050811 Unique Device ID # 10641043508114 Lot #s less than 1528850811; Part # 1050812 Unique Device ID # 10641043508121 Lot #s less than 1528850813; Part # 10508138 Unique Device ID # 10641043508004 Lot #s less than 1528850813; Part # 1050814 Unique Device ID # 106410435081454 Lot #s less than 1528850814; Part # 1050815 Unique Device ID # 10641043508152 Lot #s less than 1528850815; Part # 1050816 Unique Device ID # 10641043508169 Lot #s less than 1528850816; Part # 1050817 Unique Device ID # 10641043508176 Lot #s less than 1528850817; Part # 1050818 Unique Device ID # 10641043508183 Lot #s less than 1528850818; Part # 1050819 Unique Device ID # 10641043508190 Lot #s less than 1528850819; Part # 1050820 Unique Device ID # 10641043508206 Lot #s less than 1528850820; Part # 1050821 Unique Device ID # 10641043508213 Lot #s less than 1528850821; Part # 1050822 Unique Device ID # 10641043508220 Lot #s less than 1528850822; Part # 1050823 Unique Device ID # 10641043508237 Lot #s less than 1528850823; Part # 1050824 Unique Device ID # 10641043508244 Lot #s less than 1528850824; Part # 1050825 Unique Device ID # 10641043508251 Lot #s less than 1528850825; Part # 1050826 Unique Device ID # 10641043508268 Lot #s less than 1528850826; Part # 1050827 Unique Device ID # 10641043508275 Lot #s less than 1528850827; Part # 1050828 Unique Device ID # 10641043508282 Lot #s less than 1528850828; Part # 1050829 Unique Device ID # 10641043508299 Lot #s less than 1528850829; and Part # 1050830 Unique Device ID # 10641043508305 Lot #s less than 1528850830.  T-Piece Resucitator Circuit Part # 1050900 Lot #s less than 1528850900, Part # 1050901 Lot #s less than 1528850901, Part # 1050902 Lot #s less than 1528850902, Part # 1050903 Lot #s less than 1528850903, Part # 1050904 Lot #s less than 1528850904, Part # 1050905 Lot #s less than 1528850905, and Part # 1050914 Lot #s less than 1528850914.  T-Piece Neonatal Circuit Kit - Disposable M1091316VS Lot #s less than 15272, M1091335VS Lot #s less than 15272, and M1091365VS Lot #s less than 15272.                              
Recalling Firm/
Manufacturer		 Mercury Enterprises, Inc. dba Mercury Medical
11300 49th St N
Clearwater FL 33762-4807
For Additional Information Contact Customer Service
727-573-0088
Manufacturer Reason
for Recall		 Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
FDA Determined
Cause 2		 Device Design
Action Mercury Medical sent notification letters dated October 22, 2015, to all affected Domestic Consignees by courier and for the foreign consignees the notifications were sent via e-mail. The letter identified the product, the problem, and the action to be taken by the consignee. Customer Immediate Actions - Immediately notify all personnel subject to using these devices to remove protective cap before connecting a mask. Further this filed safety advisory notice should be read in conjuction with the manufacturer supplied instructions for use. In addition, if you further distributed this product, please identify your customers and notify them at once of this product correction. Notificatin to your customers should include a copy of this letter. For questions contact Mercury Medical at 787-573-0088, 727-573-4966 fax or via e-mail at regulatoryaffairs@mercurymed.com
Quantity in Commerce 753,245 devices
Distribution Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirate, and United Kingdom..
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 = MERCURY MEDICAL, INC.
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