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U.S. Department of Health and Human Services

Class 2 Device Recall ReadyMed Elastomeric Ambulatory Pump

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 Class 2 Recall
ReadyMed Elastomeric Ambulatory Pump
see related information
Date Posted April 07, 2009
Recall Status1 Open
Recall Number Z-1170-2009
Recall Event ID 50795
Premarket Notification
510(K) Numbers
K895797  K913658 
Product Classification Pump, Infusion - Product Code FRN
Product ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
Code Information Lot Numbers: 8105650 8105554 8105467 8105466 8105421 8105176 8105424 8105322 8105092 8105175 8105094 8105174 8105002 8105084 8105001 8105003 8096111 8096036 8095983 8095872 8095373 8095854 8095733 8095748 8095683 8095512 8095424 8095372 8095295 8095299 8095217 8095116 8095114 8095003 8095002 8095001 8095006 8085820 8085729 8085623 8085566 8085567 8085520 8085454 8085394 8085314 8085279 8085199 8085184 8085003 8085006 8085005 8085004 8085002 8085001 8075963 8075932 8075924 8075846 8075769 8075679 8075782 8075675 8075590 8075588 8075522 8075471 8075465 8075414 8075374 8075413 8075280 8075277 8075182 8075177 8075123 8075119 8075118 8075004 8075014 8075003 8075002 8075001 8065668 8065683 8065667 8065507 8065504 8065408 8065224 8065409 8065376 8065223 8065332 8065178 8065176 8065108 8065107 8065003 8065002 8065001 8055718 8055665 8055664 8055662 8055627 8055598 8055567 8055522 8055478 8055474 8055312 8055404 8055413 8055282 8055281 8055241 8055166 8055221 8055165 8055126 8055072 8055063 8055044 8055002 8055001 8055003 8046137 8046064 8046002 8045985 8045930 8045883 8045923 8045812 8045864 8045798 8045738 8045767 8045719 8045569 8045638 8045565 8045518 8045478 8045367 8045180 8045440 8045360 8045336 8045222 8045114 8045017 8035669 8045002 8045067 8045001 8035639 8035363 8035362 8035196 8035320 8035173 8035319 8035250 8035459 8035194 8035249 8035122 8035018 8035002 8035003 8035001 8025647 8025502 8025688 8025585 8025209 8025130 8025406 8025503 8025290 8025324 8025208 8025174 8025079 8025156 8025003 8025004 8015789 8025002 8025001 8015863 8015921 8015741 8015784 8015684 8015685 8015637 8015638 8015564 8015547 8015548 8015498 8015326 8015227 8015478 8015281 8015226 8015108 8015003 8015058 8015002 8015057 8015001 7125677 7125744 7125732 7125652 7125602 7125563 7125527 7125516 7125437 7125439 7125284 7125355 7125304 7125205 7125165 7125158 7125126 7125108 7115565 7125003 7125002 7115858 7125001 7115796 7115767 7115634 7115631 7115683 7115476 7115583 7115369 7115439 7115420 7115283 7115368 7115229 7115134 7115225 7115078 7115074 7115001 7115004 7115003 7105847 7105743 7105839 7105789 7105778 7105741 7105742 7105634 7105600 7105211 7105456 7105448 7105447 7105248 7105312 7105157 7105004 7105078 7105003 7105001 7105002 7095846 7095355 7095844 7095736 7095737 7095559 7095584 7095439 7095237 7095440 7095175 7095135 7095093 7095004 7095003 7095002 7095001 7088687 7088517 7088516 7088515 7088550 7088309 7088381 7088308 7088305 7088199 7088198 7088184 7088185 7088112 7088110 7088111 7085260 7085259 7085166 7085222 7085051 7085003 7085167 7085123 7085002 7085145 7085005 7085001 7076045 7075841 7075709 7075792 7075708 7075580 7075678 7075476 7075352 7075448 7075447 7075159 7075405 7075068 7075160 7075066 7075005 7075002 7075001 7075004 7075003 7065851 7065897 7065850 7065763 7065762 7065647 7065736 7065544 7065601 7065602 7065510 7065418 7065179 7065366 7065004 7065309 7065127 7065231 7065036 7065003 7065002 7065001 7055764 7055654 7055714 7055653 7055631 7055548 7055537 7055536 7055521 7055296 7055378 7055224 7055222 7055175 7055001 7055174 7055078 7055061 7055003 7055002 7045756 7045755 7045681 7045577 7045682 7045515 7045512 7045466 7045269 7045467 7045397 7045347 7045313 7045060 7045224 7045177 7045172 7045119 7045118 7045061 7045055 7045002 7045001 7045003 7035919 7035815 7035799 7035818 7035798 7035656 7035769 7035490 7035489 7035600 7035451 7035448 7035243 7035297 7035181 7035125 7035124 7035003 7035002 7035001 7025703 7025604 7025614 7025604 7025528 7025459 7025423 7025370 7025315 7025284 7025188 7025091 7025069 7025054 7025038 7025037 7015881 7015841 7015737 7015736 7015626 7015619 7015475 7015091 7015406 7015474 7015409 7015408 7015330 7015407 7015329 7015279 7015280 7015236 7015235 7015194 7015193 7015090 7015045 7015041 7015040 7015001 6125411 6125326 6125553 6125552 6125124 6125119 6125118 6125433 6125410 6125123 6125262 6125261 6125325 6125001 6125122 6125002 6125117 6125050 6125003 6115978 6115829 6115769 6115768 6115540 6115539 6115394 6115521 6115392 6115393 6115325 6115364 6115324 6115180 6115071 6115178 6115069 6115010 6115066 6115008 6115007 6115009 6105796 6105732 6105795 6105794 6105689 6105731 6105688 6105661 6105660 6105594 6105593 6105554 6105553 6105173 6105474 6105465 6105464 6105304 6105305 6105172 6105303 6105117 6105108 6105040 6105039, and 6095621.
Recalling Firm/
Manufacturer
Cardinal Health 303 dba Cardinal Health
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
Manufacturer Reason
for Recall
The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.
FDA Determined
Cause 2
DESIGN: Process Design
Action Cardinal sent an Urgent: Medical Device Recall Notification letter, dated 12/19/2008, to consignees on December 22, 2008 stating the Public Reason for Recall, and informing them of the Short Term and Long Term Actions. In addition a modification to the "Dear Pharmacist" letter, FAQ and Recall Response Card was mailed beginning January 26, 2009 to clarify that the pharmacist's ReadyMed products should be sent directly to their distributor and the credit for their product will also be provided through their distributor. Cardinal Health will work directly with the distributor and not the pharmacist as they are not Cardinal Health's direct consignee. Short Term: All ReadyMed elastomeric ambulatory infusion system models are subject to this recall. Cardinal Health is requesting that the use of the ReadyMed elastomeric ambulatory infusion system be discontinued and that the product be returned to Cardinal Health for credit. -Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card. Note on the card the ReadyMed elastomeric ambulatory infusion system models, lot numbers and quantities that will be returned. Cardinal will provide a courier mailing package for that return and will process consignees' credit. -Customers who purchased through a distributor will receive their credit through that distributor and not directly from Cardinal Health. -Consignee distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the Cardinal Health ReadyMed Recall Call Center at the number below. -Enclosed is a Frequently Asked Questions (FAQ) Letter for Pharmacists to address any questions or concerns related to the use of the ReadyMed elastomeric ambulatory infusion system. Long Term Actions: cardinal Health is continuing to investigate the out of specification condition of the ReadyMed elastomeric ambulatory infusion system and reviewing possible corrective measu.
Quantity in Commerce Approximately 2.6 million units
Distribution Nationwide Distribution
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 = FRN and Original Applicant = IMED CORP.
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