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U.S. Department of Health and Human Services

Class 2 Device Recall Gravity and Infusion Pump Intravenous (IV) Sets using the Ysite Ultrasite Valve

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  Class 2 Device Recall Gravity and Infusion Pump Intravenous (IV) Sets using the Ysite Ultrasite Valve see related information
Date Initiated by Firm April 14, 2003
Date Posted June 12, 2003
Recall Status1 Terminated 3 on January 29, 2004
Recall Number Z-0933-03
Recall Event ID 26226
510(K)Number K790062  K955585  K943770  K760383  K942988  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.
Code Information Catalog #352004 - Lot #s 0060390643, 0060390644, 0060395269, 60395272, 60429525, 0060411651, 0060426960, 0060429525, and 0060430054. Catalog #352049 - Lot #s 0060381759, 0060384115, 0060386555, 0060388678, 0060391072, 0060392950, 0060397344, 0060399612, 0060405055, 0060406467, 0060408425, 0060410255, 0060411638, 0060412823, 0060419500, 0060421552, 0060426399, 0060429531, 0060430749, 0060435319, 0060437596, and 0060437913. Catalog #352051 - Lot #s 0060419038 and 0060419039. Catalog #352222 - Lot #s 0060381626, 0060386862, 0060390599, 0060393331, 0060397325, 0060411966, 0060417244, 0060420643, and 0060429830. Catalog #352223 - Lot #s 0060395209, 0060420353, and 0060432419.  Catalog #352224 - Lot # 0060374720 Catalog #352225 - Lot #s 0060406237, 0060411540, and 0060417245. Catalog #352237 - Lot #s0060386868, 0060384090, 0060397352, 006042859, 0060435289 and 0060393337. Catalog #352238 - Lot #s 0060379443, 0060413601, 0060419352 and 0060397391. Catalog #352340 - Lot # 0060399651 Catalog #352341 - Lot #0060419800 Catalog #352342 - Lot #s 0060385368 and 0060386187 Catalog #352355 - Lot #s 0060381731, 0060386533, 0060405539, and 0060421540. Catalog #352356 - Lot #s 0060384095, 0060405753, 0060412569, 0060419498, and 0060428603. Catalog #352362 - Lot # 0060390627 Catalog #352379 - Lot #s 0060386755 and 0060390530 Catalog #352393 - Lot #s 0060379061, 0060386808, 0060390531, 0060395158, 0060397119, and 0060417162. Catalog #352396 - Lot #s 0060379062, 0060385889, 0060390534, 0060397122, and 0060408823. Catalog #352406 - Lot #s 0060388274, 0060395165, 0060397235, 0060408828, 0060411870, and 0060420593. Catalog #352409 - Lot # 0060388275 Catalog #352413 - Lot #s 0060397890, 0060409013, 0060411626, and 0060411975. Catalog #352420 - Lot #s 0060406524, 0060412700, 0060421691, 0060432013, 0060432988, and 0060433472. Catalog #352421 - Lot #s 0060404049, and 0060411708. Catalog #352422 - Lot #s 0060404062, 006040908, and 0060417538. Catalog #352423 - Lot # 0060404052 Catalog #352444 - Lot # 0060417840 Catalog #352446 - Lot # 0060417838 Catalog #352455 - Lot #0060417841 Catalog #375038 - Lot #s 0060406603 and 0060408468 Catalog #375084 - Lot #s 0060397187 and 0060422174 Catalog #375088 - Lot #s 0060381216, 0060386872, and 0060417250. Catalog #375090 - Lot #s 0060386873, 0060411552, and 0060417251. Catalog #375100 - Lot #s 0060381725, 0060384081, 0060384082, 0060385182, 0060388670, 0060388671, 0060391024, 0060395171, 0060395185, 0060398414, 0060403467, 0060403471, 0060408406, 0060408407, 0060408408, 0060410249, 0060411025, 0060412517, 0060412992, 0060413598, 0060418255, 0060418257, 0060418455, and 0060421541. Catalog #375101 - Lot #s 0060386532, 0060395172, 0060399599, 0060406462, 0060410025, 0060418444, 0060426298, 0060427317, and 0060438111.  Catalog #375105 - Lot #s 0060391170, 0060397412, 0060399667, 0060403501, 0060405234, 0060410306, 0060412697, 0060424455, 0060427890, 0060430736, and 0060432994. Catalog #375135 - Lot # 0060393350 Catalog #375151 - Lot #s 0060399411, 0060408845, and 0060424446. Catalog #375155 - Lot #s 0060408847 and 0060419024. Catalog #472033 - Lot #s 0060373796, 0060373797, 0060373800, 0060378892, 0060378893, and 0060378894. Catalog #473436 - Lot #s 0060385366, 0060386542, 0060395227, 0060423199, 0060424318, 0060425256, 0060425671, 0060428044, and 0060432415. Catalog #473992 - Lot # 0060432401 Catalog #474516 - Lot # 0060401098 Catalog #474577 - Lot #s 0060381183, 0060382531, 0060388314, and 0060411522. Catalog #474912 - Lot #s 0060398364 and 0060417227. Catalog #CC1260-SP02 - Lot #s 0060428236, 0060432935, 0060438115, and 0060432936. Catalog #S5403001N - Lot #s 0060378529, 0060380587, 0060387639, 0060392813, and0060407453. Catalog #S9903301N - Lot # 0060418246 Catalog #US1380 - Lot #s 0060391069 and 0060403474. Catalog #US3115 - Lot #s0060387950, 0060388508, 0060406192, 0060410297, 0060419358, 0060419972, 0060426441, and 0060428624. Catalog #US3116 - Lot # 0060410763 Catalog #US3120 - Lot #s 0060386610, 0060397408, 0060406515, 0060410310, 0060413656, 0060424458, 0060427887, and0060435342. Catalog #US3130 - Lot #s 0060381801, 0060384195, 0060386619, 0060386621, 0060386792, 0060387920, 0060387921, 0060388758, 0060390219, 0060391167, 0060391168, 0060393010, 0060395363, 0060395364, 0060395373, 0060397407, 0060398938, 0060403494, 0060403495, 60405210, 60408590, 0060406071, 0060408480, 0060408485, 0060408590, 0060412691, 0060412692, 0060413650, 0060413651, 0060417595, 0060418182, 0060419378, 0060419381, 0060419384, 0060421685, 0060421687, 0060423935, 0060424451, 0060424452, 0060424453, 0060424459, 0060424460, 0060424699, 0060425148, 0060426360, 0060426361, 0060427884, 0060427885, 006040058, 0060430943, 0060430944, 0060430945, 0060435339, 0060435816, 0060437605, 0060437607, and 0060437609. Catalog #US3131 - Lot #s 0060385347, 0060385365, and 0060386180. Catalog #US3169 - Lot #s 0060397410 and 0060413655. Catalog #US3485 - Lot #s 0060384044, 0060397229, 0060408385, 0060410245, 0060413662, 0060420137, 0060421697, 0060432014, and 0060435399. Catalog #US3488 - Lot #s 0060386525 and 0060412568. Catalog #US5300 -Lot #s S-0776, S-0777, S-0778, S-0903, 30049, 30096, 30149, and 30150. Catalog #US6413 - Lot #s 0060381721, 0060397240, 0060403462, 0060411045, 0060411635, 0060412564, 0060418436, and 0060432400. Catalog #US6415 - Lot #s 0060386526 and 0060412567. Catalog #V5534-SP02 - Lot #s 0060405704 and 0060417228.
Recalling Firm/
Manufacturer		 Braun,B Medical Inc
901 Marcon Blvd
Allentown PA 18103
For Additional Information Contact Art Morse
610-266-0500
Manufacturer Reason
for Recall		 possible leakage
FDA Determined
Cause 2		 Other
Action The recalling firm sent recall letters to their direct accounts dated 4/14/03. The recall letters inform the accounts of the problem and the need to return the product.
Quantity in Commerce 2577300 units
Distribution The products were shipped to medical facilities and distributors nationwide. The products were also shipped to the firm''s German facility, Canada and Spain.
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 = FPA and Original Applicant = B. BRAUN INSTRUMENTS
510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = B. BRAUN OF AMERICA, INC.
510(K)s with Product Code = FPA and Original Applicant = NATIONAL PATENT DEVELOPMENT CORP.
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