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.
- Company
- Braun, B Medical Inc
- Recall Initiated
- April 14, 2003
- Posted
- June 12, 2003
- Terminated
- January 29, 2004
- Recall Number
- Z-0933-03
- Quantity
- 2577300 units
- Firm Location
- Allentown, PA
Reason for Recall
possible leakage
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.