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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Intego PET Infusion System

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  Class 2 Device Recall MEDRAD Intego PET Infusion System see related information
Date Initiated by Firm September 30, 2016
Date Posted November 11, 2016
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0400-2017
Recall Event ID 75387
510(K)Number K080297  K100798  
Product Classification Pump, infusion - Product Code FRN
Product PET Infusion Pump
Code Information Impacted Batch Numbers: 20044 8401230 20110777 20110778 20129053 20130260 20143029 20168043 20168044 20218499 20223554 20226461 20229069 50378230 50508655 50514420 50515055 50515057 50562833 50562834 50562835 50562836 50572481 50574207 50574208 50574209 50585611 50586105 50596605 50597703 50597850 50600435 50601580 50602572 50604785 50606331 50620077 50629437 50632873 50634213 50657181 50663447 50665086 50669881 50677540 50686154 50688724 50693453 50695189 50696540 50696563 50698651 50699741 50699882 50699883 50705397 50705398 50718205 50718756 50720431 50721421 50725617 50725618 50731457 50735273 50738861 50740290 50743615 50747279 50748947 50750243 50752501 50755005 50781643 50782219 50783201 50784811 50786091 50786092 50786096 50789117 50789131 50789132 50792077 50793811 50795111 50798463 50801293 50801294 50804590 50804591 50808994 50812469 50826288 50826491 50826492 50827614 50827615 50828779 50831229 50831230 50833827 50834754 50836287 50837233 50838024 50840343 50840344 50841688 50843787 50845969 50847291 50848267 50848268 50848269 50853167 50855436 50856405 50857510 50860994 50866789 50867921 50869464 50869465 50871131 50872965 50878229 50878230 50878231 50878232 50881328 50881393 50881394 50881395 50881506 50881511 50881512 50882753 50886316 50886467 50886468 50886469 50888285 50888286 50888287 50888373 50890483 50890484 50890485 50892357 50892358 50892359 50892360 60000321 60000790 60000833 60000835 60000914 60000973 60001065 60001078 60001558 60001766 60001767 60001864 60002113 60002164 60002324 60002467 60002845 60002846 60003127 60003128 60003256 60003265 60003368 60003703 60004022 60004099 60004159 60004454 60004625 60004711 60005487 60006206 60006545 60006624 60007219 60007220 60007221 60007925 60008270 60008271 60008539 60008540 60008541 
Recalling Firm/
Manufacturer		 Bayer Healthcare
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact
412-767-2400
Manufacturer Reason
for Recall		 The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
FDA Determined
Cause 2		 Process control
Action Bayer mailed an Urgent Medical Device Customer Notification letter to the affected consignees on September 30, 2016 asking that they review their current SAS inventory and determine if you have any product that is more than one year past its manufacturing date, Quarantine unused units and call Bayer Customer Care line to receive a Return Goods Authorization (RGA) number for the product's return.
Quantity in Commerce 165,127 (79,714 units in U.S.)
Distribution Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,
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 = FRN and Original Applicant = MEDRAD, INC.
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