Rappel de Device Recall Medline Custom Sterile Surgical Packs

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medline Industries, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    31315
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0554-05
  • Date de mise en oeuvre de l'événement
    2005-03-04
  • Date de publication de l'événement
    2005-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2006-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    General Surgery Tray - Product Code LRO
  • Cause
    There is a potential for open side seals post-sterilization of the tyvek breather pouches used in the custom sterile packs.
  • Action
    Field Correction letters dated 3/4/05 were sent to thedirect account hospitals on the same date to the attention of the manager of surgery, informing them of the potential indadequate side seal of the Tyvek breather pouches in the packs which may cause a compromise in the sterility of the product. The accounts were provided a list of the affected pack sent to the account and were requested to inspect any stocks of the affected product in stock, using the enclosed diagrams as an aid in the inspection for the defective side seals. Any defective product found should be returned to Medline. Any questions were directed to Lara Simmons, QA/RA Director at 1-800-879-2781, ext. 6072.

Device

  • Modèle / numéro de série
    all lots distributed between 6/15/04 and 3/1/05 of the following reorder numbers: DYNJ02170A, DYNJ02176A, DYNJ02179B, DYNJ02182A, DYNJ04314A, DYNJ04316, DYNJ04321, DYNJ04325, DYNJ04329, DYNJ04336B, DYNJ04338B, DYNJ04371, DYNJ04383, DYNJ04388, DYNJ04407A, DYNJ04408A, DYNJ04419A, DYNJ04427, DYNJ04455, DYNJ04468B, DYNJ04472A, DYNJ04476, DYNJ04478A, DYNJ04481B, DYNJ04482, DYNJ04483, DYNJ04485, DYNJ04494, DYNJ04497, DYNJ04502, DYNJ04504, DYNJ04505, DYNJ04509, DYNJ04542, DYNJ04545, DYNJ04548A, DYNJ04556A, DYNJ04557B, DYNJ04558A, DYNJ04572, DYNJ04579A, DYNJ04597, DYNJ04609, DYNJ04611A, DYNJ04620A, DYNJ04629B, DYNJ04676A, DYNJ04677, DYNJ04683, DYNJ04691, DYNJ04709A, DYNJ04710, DYNJ04711, DYNJ04711A, DYNJ04712, DYNJ04713A, DYNJ04720A, DYNJ04723, DYNJ04729, DYNJ04744, DYNJ04745A, DYNJ04754A, DYNJ04805A, DYNJ04807A, DYNJ04811, DYNJ04822A, DYNJ04825A, DYNJ04832, DYNJ04834, DYNJ04840, DYNJ04841, DYNJ04878, DYNJ04880, DYNJ04888, DYNJ05787K, DYNJ05798K, DYNJ06075G, DYNJ06324L, DYNJ06682B, DYNJ06739B, DYNJ06743A, DYNJ06744B, DYNJ06782A, DYNJ06796J, DYNJ06839A, DYNJ06873A, DYNJ06876D, DYNJ06876F, DYNJ06908B, DYNJ06927A, DYNJ06930F, DYNJ06952F, DYNJ06976, DYNJ07536, DYNJ07537C, DYNJ07626A, DYNJ07626A, DYNJ07626A, DYNJ07670C, DYNJ07833F, DYNJ07881C, DYNJ07910A, DYNJ07942, DYNJ07942, DYNJ07951A, DYNJ07954A, DYNJ07954A, DYNJ07982A, DYNJ07995, DYNJ08351K, DYNJ08387F, DYNJ08601A, DYNJ08671I, DYNJ08713C, DYNJ08796D, DYNJ08802, DYNJ08814F, DYNJ08815D, DYNJ08816C, DYNJ08840J, DYNJ08844I, DYNJ09066C, DYNJ09156F, DYNJ09174D, DYNJ09188A, DYNJ09194F, DYNJ09258R, DYNJ09259I, DYNJ09261J, DYNJ09294B, DYNJ09322D, DYNJ09343F, DYNJ09346, DYNJ09397A, DYNJ09398, DYNJ09449C, DYNJ09515C, DYNJ09528D, DYNJ09531D, DYNJ09532F, DYNJ09533F, DYNJ09590D, DYNJ09617B, DYNJ09619D, DYNJ09624A, DYNJ09677A, DYNJ09677C, DYNJ09681C, DYNJ09682B, DYNJ09684B, DYNJ09694A, DYNJ09703B, DYNJ09787B, DYNJ09807K, DYNJ09857B, DYNJ09858A, DYNJ09874C, DYNJ09875G, DYNJ09882A, DYNJ09921, DYNJ09923, DYNJ09932B, DYNJ09933, DYNJ09941C, DYNJ09981A, DYNJ14000A, DYNJ14002, DYNJ14005A, DYNJ14006, DYNJ14008A, DYNJ14014, DYNJ14017A, DYNJ14018A, DYNJ14024, DYNJ14038, DYNJ14039, DYNJ14069A, DYNJ14078A, DYNJ14079, DYNJ14095A, DYNJ14096B, DYNJ14097, DYNJ14107, DYNJ14107, DYNJ14110, DYNJ14112A, DYNJ14114, DYNJ14119, DYNJ14127, DYNJ14130, DYNJ14134, DYNJ14137, DYNJ14147A, DYNJ14148A, DYNJ14149A, DYNJ14150A, DYNJ14156B, DYNJ14157B, DYNJ14170, DYNJ14187, DYNJ14218A, DYNJ14225A, DYNJ15062, DYNJ15332A, DYNJ15392D, DYNJ15393G, DYNJ15428F, DYNJ15455P, DYNJ15494A, DYNJ15504D, DYNJ15519A, DYNJ15615D, DYNJ15643L, DYNJ15660C, DYNJ15660D, DYNJ15668D, DYNJ15703A, DYNJ15751C, DYNJ15752, DYNJ15814I, DYNJ15903C, DYNJ15956B, DYNJ15980A, DYNJ16018F, DYNJ16025B, DYNJ16026B, DYNJ16065A, DYNJ16072D, DYNJ16076I, DYNJ16079B, DYNJ16082B, DYNJ16114F, DYNJ16127C, DYNJ16131B, DYNJ16206A, DYNJ16250C, DYNJ16263C, DYNJ16274B, DYNJ16280B, DYNJ16284, DYNJ16289B, DYNJ16327C, DYNJ16327D, DYNJ16342, DYNJ16346A, DYNJ16350C, DYNJ16376C, DYNJ16379B, DYNJ16381C, DYNJ16384, DYNJ16435, DYNJ16461C, DYNJ16510D, DYNJ16514B, DYNJ16518A, DYNJ16535A, DYNJ16536A, DYNJ16541B, DYNJ16567C, DYNJ16575, DYNJ16577, DYNJ16589, DYNJ16591, DYNJ16604, DYNJ16604A, DYNJ16623, DYNJ16625, DYNJ16644, DYNJ17003A, DYNJ17008, DYNJ17016A, DYNJ17018, DYNJ17020, DYNJ17042, DYNJ17044, DYNJ17045A, DYNJ17053, DYNJ17065, DYNJ17068, DYNJ17082, DYNJ19022D, DYNJ19023C, DYNJ19029A, DYNJ19051B, DYNJ19061D, DYNJ19069B, DYNJ19073B, DYNJ19081D, DYNJ19109A, DYNJ19121, DYNJ19138C, DYNJ19139A, DYNJ19146C, DYNJ19146D, DYNJ19154B, DYNJ19170B, DYNJ19199A, DYNJ19230D, DYNJ19233B, DYNJ19234B, DYNJ19235A, DYNJ19249B, DYNJ19251A, DYNJ19256B, DYNJ19257A, DYNJ19296C, DYNJ19329C, DYNJ19371, DYNJ19390B, DYNJ19395B, DYNJ19416B, DYNJ19418D, DYNJ19419A, DYNJ19419B, DYNJ19441D, DYNJ19451I, DYNJ19461B, DYNJ19468A, DYNJ19469, DYNJ19479A, DYNJ19483, DYNJ19500A, DYNJ19501B, DYNJ19509C, DYNJ19515, DYNJ19527D, DYNJ19529A, DYNJ19550A, DYNJ19551B, DYNJ19564A, DYNJ19589A, DYNJ19590A, DYNJ19603B, DYNJ19611B, DYNJ19612B, DYNJ19620A, DYNJ19637G, DYNJ19638F, DYNJ19646D, DYNJ19655A, DYNJ19657, DYNJ19674B, DYNJ19675D, DYNJ19679D, DYNJ19684A, DYNJ19686, DYNJ19694A, DYNJ19696A, DYNJ19697A, DYNJ19699A, DYNJ19709C, DYNJ19710B, DYNJ19724A, DYNJ19726A, DYNJ19729A, DYNJ19730B, DYNJ19738, DYNJ19771B, DYNJ19775A, DYNJ19777A, DYNJ19777A, DYNJ19787B, DYNJ19788A, DYNJ19789A, DYNJ19790B, DYNJ19791D, DYNJ19804B, DYNJ19813, DYNJ19814A, DYNJ19816A, DYNJ19830, DYNJ19833, DYNJ19842A, DYNJ19850B, DYNJ19853, DYNJ19880B, DYNJ19882B, DYNJ19885B, DYNJ19887B, DYNJ19888, DYNJ19900C, DYNJ19901D, DYNJ19907, DYNJ19910, DYNJ19918B, DYNJ19919B, DYNJ19923, DYNJ19929A, DYNJ19929B, DYNJ19933G, DYNJ19935F, DYNJ19938, DYNJ19944, DYNJ19949A, DYNJ19951B, DYNJ19953A, DYNJ19955A, DYNJ19960B, DYNJ19964B, DYNJ19981A, DYNJ19997F, DYNJ20004F, DYNJ20007C, DYNJ20010A, DYNJ20012A, DYNJ20013A, DYNJ20020A, DYNJ20021A, DYNJ20026A, DYNJ20027A, DYNJ20028A, DYNJ20029, DYNJ20030B, DYNJ20031, DYNJ20034, DYNJ20040A, DYNJ20053B, DYNJ20055A, DYNJ20079A, DYNJ20081A, DYNJ20084, DYNJ20104, DYNJ20106A, DYNJ20107, DYNJ20114C, DYNJ20115, DYNJ20117, DYNJ20124A, DYNJ20125, DYNJ20126A, DYNJ20127A, DYNJ20134B, DYNJ20135C, DYNJ20137A, DYNJ20138B, DYNJ20142A, DYNJ20151B, DYNJ20169, DYNJ20170, DYNJ20181, DYNJ20185, DYNJ20186, DYNJ20187A, DYNJ20198A, DYNJ20200, DYNJ20202A, DYNJ20208, DYNJ20211A, DYNJ20213A, DYNJ20214A, DYNJ20215A, DYNJ20216, DYNJ20218A, DYNJ20221A, DYNJ20230, DYNJ20232, DYNJ20248B, DYNJ20252, DYNJ20335A, DYNJ20354A, DYNJ20355B, DYNJ20397A, DYNJ20405, DYNJ20409, DYNJ20422, DYNJ20425B, DYNJ20433, DYNJ20440A, DYNJ20441, DYNJ20442, DYNJ20462B, DYNJ20463, DYNJ20465B, DYNJ20466A, DYNJ20468B, DYNJ20472B, DYNJ20485B, DYNJ20487B, DYNJ20488B, DYNJ20489, DYNJ20489B, DYNJ20490A, DYNJ20491B, DYNJ20495B, DYNJ20496A, DYNJ20498A, DYNJ20498B, DYNJ20502B, DYNJ20503A, DYNJ20507A, DYNJ20508A, DYNJ20509B, DYNJ20518C, DYNJ20521A, DYNJ20522, DYNJ20522A, DYNJ20540B, DYNJ20567B, DYNJ20567B, DYNJ20609A, DYNJ20609B, DYNJ20639A, DYNJ20643A, DYNJ20696A, DYNJ20738, DYNJ20767B, DYNJ20775B, DYNJ20788B, DYNJ20789B, DYNJ20792, DYNJ20792, DYNJ20794, DYNJ20797A, DYNJ20806A, DYNJ20810, DYNJ20829A, DYNJ20834, DYNJ20838A, DYNJ20844A, DYNJ20846A, DYNJ20870, DYNJ20872A, DYNJ20888A, DYNJ20890A, DYNJ20891A, DYNJ20899, DYNJ20910, DYNJ20911A, DYNJ20913, DYNJ20928B, DYNJ20932B, DYNJ20933A, DYNJ20942A, DYNJ20955, DYNJ20994, DYNJ21003, DYNJ21011B, DYNJ21016, DYNJ21018, DYNJ21019A, DYNJ21020B, DYNJ21030, DYNJ21049A, DYNJ21063A, DYNJ21073B, DYNJ21088C, DYNJ21096, DYNJ21097, DYNJ21100A, DYNJ21123, DYNJ21140, DYNJ21149, DYNJ21149A, DYNJ21175A, DYNJ21183, DYNJ21187A, DYNJ21190, DYNJ21191, DYNJ21193, DYNJ21226, DYNJ21249, DYNJ21265, DYNJ21294A, DYNJ21296A, DYNJ21304, DYNJ21307A, DYNJ21307B, DYNJ21320, DYNJ21322, DYNJ21324B, DYNJ21327A, DYNJ21328B, DYNJ21329A, DYNJ21378, DYNJ21399A, DYNJ21400, DYNJ21404B, DYNJ21405A, DYNJ21406A, DYNJ21425, DYNJ21451A, DYNJ21452, DYNJ21475, DYNJ21476, DYNJ21484, DYNJ21485, DYNJ21491, DYNJ21494, DYNJ21497, DYNJ21497A, DYNJ21511, DYNJ21513, DYNJ21526, DYNJ21527, DYNJ21529, DYNJ21530, DYNJ21540, DYNJ21545, DYNJ21557, DYNJ21562, DYNJ21567, DYNJ21569, DYNJ21584, DYNJ21601, DYNJ21633, DYNJ21635, DYNJ21635A, DYNJ21677, DYNJ21718, DYNJ21721, DYNJ21722, DYNJ21726, DYNJ21728, DYNJ21736, DYNJ21737, DYNJ21739, DYNJ21777A, DYNJ21785, DYNJ21792A, DYNJ21797, DYNJ21798, DYNJ21803, DYNJ21804, DYNJ21805, DYNJ21817, DYNJ21818, DYNJ21826, DYNJ21827, DYNJ21828, DYNJ21839, DYNJ21886, DYNJ21965, DYNJ25096D, DYNJ25104D, DYNJ25167B, DYNJ25222B, DYNJ25229C, DYNJ25235C, DYNJ25240A, DYNJ25243A, DYNJ25270C, DYNJ25421A, DYNJ25458, DYNJ25461A, DYNJ25468C, DYNJ25538A, DYNJ25605B, DYNJ25624B, DYNJ25645B, DYNJ25715, DYNJ25757B, DYNJ25792A, DYNJ25795, DYNJ25796A, DYNJ25821A, DYNJ25825B, DYNJ25827A, DYNJ25829A, DYNJ25831B, DYNJ25891D, DYNJ25896B, DYNJ25896B, DYNJ25908, DYNJ25925, DYNJ25929, DYNJ25935A, DYNJ25936A, DYNJ25941A, DYNJ25957, DYNJ25987B,  DYNJ26045A, DYNJ26045A, DYNJ26078A, DYNJ26100A, DYNJ26123A, DYNJ26171C, DYNJ26172C, DYNJ26178A, DYNJ26181A, DYNJ26189, DYNJ26190A, DYNJ26191A, DYNJ26192B, DYNJ26193B, DYNJ26196A, DYNJ26197, DYNJ26237A, DYNJ26241B, DYNJ26257B, DYNJ26260A, DYNJ26277, DYNJ26278, DYNJ26289, DYNJ26294, DYNJ26294, DYNJ26325, DYNJ26394A, DYNJ26420A, DYNJ26448, DYNJ26453A, DYNJ26455, DYNJ26459B, DYNJ26566, DYNJ26570, DYNJ26573, DYNJ26608, DYNJ26635A, DYNJ26685, DYNJ26724A, DYNJ26726, DYNJ26730, DYNJ26732, DYNJ26733A, DYNJ26750, DYNJ26753, DYNJ26757, DYNJ26761, DYNJ26764, DYNJ26776, DYNJ26786B, DYNJ26848, DYNJ26848A, DYNJ26849A, DYNJ26850, DYNJ26852, DYNJ26853, DYNJ26873, DYNJ26891, DYNJ26901, DYNJ26901A, DYNJ26922, DYNJ26937, DYNJ26956A, DYNJ26964, DYNJ26964A, DYNJ26988, DYNJ26993, DYNJ27055, DYNJ27073, DYNJ27088, DYNJ27110, DYNJ27154, DYNJ27154, DYNJ27160, DYNJ27165, DYNJ27173, DYNJ27234, DYNJ27273, DYNJ27278, DYNJ27309, DYNJ27313, DYNJ27315, DYNJ27337, DYNJ27412, DYNJ27438, DYNJC1028F, DYNJC1030G, DYNJC1131B, DYNJC1254J, DYNJC1267F, DYNJC1361G, DYNJC1382D, DYNJC1517D, DYNJC1520C, DYNJC1541G, DYNJC1542C, DYNJC1639G, DYNJC1657G, DYNJC1748B, DYNJC1753F, DYNJC1754A, DYNJC1834G, DYNJC1877A, DYNJC1910F, DYNJC1912C, DYNJC1916B, DYNJC1981F, DYNJC1986N, DYNJC2023I, DYNJC2202N, DYNJC2229L, DYNJC2237A, DYNJC2274G, DYNJC2281F, DYNJC2287B, DYNJC2288, DYNJC2338B, DYNJC2373B, DYNJC2375B, DYNJC2393A, DYNJC2399A, DYNJC2413B, DYNJC2414B, DYNJC2418, DYNJC2419G, DYNJC2420D, DYNJC2422B, DYNJC2427B, DYNJC2431G, DYNJC2431I, DYNJC2460A, DYNJC2484C, DYNJC2485, DYNJC2588D, DYNJC2606G, DYNJC2684D, DYNJC2701A, DYNJC2714A, DYNJC2715A, DYNJC2758JDYNJC2759I , DYNJC2760I, DYNJC2762J, DYNJC2763G, DYNJC2764G, DYNJC2766G, DYNJC2767I, DYNJC2768N, DYNJC2769I, DYNJC2794B, DYNJC2821, DYNJC2848C, DYNJC2915D, DYNJC2956D, DYNJC2985A, DYNJC2994D, DYNJC3091F, DYNJC3110C, DYNJC3117D, DYNJC3118G, DYNJC3137A, DYNJC3143G, DYNJC3184D, DYNJC3186C, DYNJC3187C, DYNJC3188D, DYNJC3191C, DYNJC3225C, DYNJC3256A, DYNJC3259B, DYNJC3276, DYNJC3279C, DYNJC3280B, DYNJC3292C, DYNJC3294A, DYNJC3299A DYNJC3304A, DYNJC3349C, DYNJC3360A, DYNJC3362A, DYNJC3367C, DYNJC3380A,  DYNJC3417, DYNJC3418, DYNJH1054I, DYNJH1060B, DYNJH1158A, DYNJH1223C, DYNJH1227A, DYNJH1235F, DYNJH1236, DYNJHS0116F, DYNJHS0145A, DYNJHS0181C, DYNJHS0570, DYNJHS0597A, DYNJHS0597B, DYNJHS0604C, DYNJHS0605C, DYNJHS0628, DYNJHS0709B, DYNJQ0009A, DYNJQ0020A, DYNJQ0029D, DYNJQ0043, DYNJQ0059F, DYNJQ0060B, DYNJQ0063B, DYNJQ0064F, DYNJQ0097A, DYNJQ0100A, DYNJQ0114, DYNJQ0118B, DYNJQ0119B, DYNJQ0120A, DYNJQ0123A, DYNJQ0124B, DYNJQ0127, DYNJQ0128A, DYNJQ0131A, DYNJQ0140C, DYNJQ0157D, DYNJQ0162B, DYNJQ0171A, DYNJQ0172, DYNJQ0177A, DYNJQ0178C, DYNJQ0180B, DYNJQ0185A, DYNJQ0191F, DYNJQ0207, DYNJQ0221, DYNJQ0226C, DYNJQ0227B, DYNJQ0234A, DYNJQ0235A, DYNJQ0237A, DYNJQ0240A, DYNJQ0242A, DYNJQ0244B, DYNJQ0271, DYNJQ0286D, DYNJQ0299A, DYNJQ0301A, DYNJQ0304A, DYNJQ0306B, DYNJQ0308B, DYNJQ0320A, DYNJQ0338A, DYNJQ0365A, DYNJQ0369A, DYNJQ0370A, DYNJQ0376B, DYNJQ0405A, DYNJQ0411A, DYNJQ0415, DYNJQ0439B, DYNJQ0461A, DYNJQ0486, DYNJQ0497, DYNJQ0508, DYNJQ0526, DYNJQ0529, DYNJQ0541A, DYNJQ0543, DYNJQ0564, DYNJQ0567, DYNJQ0578, DYNJQ0584, DYNJSB0013, DYNJT0017G, DYNJT0018I, DYNJT0019I, DYNJT0055B, DYNJT0056A, DYNJT0087B, DYNJT0162D, DYNJT0225C, DYNJT0258A, DYNJT0483A, DYNJT0505B, DYNJT0507F, DYNJT0616B, DYNJT0617A, DYNJT0627G, DYNJT1076G, DYNJT1077J, DYNJT1081G, DYNJT1083F, DYNJT1084B, DYNJT1085G, DYNJT1107B, DYNJT1185C, DYNJT1187F, DYNJT1259B, DYNJT1273, DYNJT1282B, DYNJT1299B, DYNJT1302B, DYNJT1416F, DYNJT1459, DYNJT1485B, DYNJT1589A, DYNJT1678A, DYNJT1679C, DYNJT1695A, DYNJT1745F, DYNJT1759B, DYNJT1877B, DYNJT1878, DYNJT1901C, DYNJT1926B, DYNJT1927A, DYNJT1936, DYNJT1938, DYNJT1943A, DYNJT1945A, DYNJT1947, DYNJT1972D, DYNJT2003, DYNJT2014C, DYNJT2110B, DYNJT2119A, DYNJT2121B, DYNJT2144A, DYNJT2159C, DYNJT2179, DYNJT2180D, DYNJT2185A, DYNJT2248A, DYNJT2262, DYNJT2388A, DYNJT2432A, DYNJT2444, DYNJT2445, DYNJT2484C, DYNJV0039F, DYNJV0067I, DYNJV0069C, DYNJV0071G, DYNJV0073C, DYNJV0076A, DYNJV0078C, DYNJV0079D, DYNJV0083C, DYNJV0098B, DYNJV0100D, DYNJV0107F, DYNJV0160C, DYNJV0196B, DYNJV0218, DYNJY0001A, DYNJY0003A, DYNJY0010, DYNJY0019B, DYNJY0041B, DYNJY0042A, DYNJY0050B, DYNJY0056B, DYNJY0057C, DYNJY0059B, DYNJY0060C, DYNJY0064D, DYNJY0067C, DYNJY0069, DYNJY0074B, DYNJY0075A, DYNJY0080A, DYNJY0083B, DYNJY0085A, DYNJY0090, DYNJY0097A, DYNJY0098A, DYNJY0102A, DYNJY0110B, DYNJY0112A, DYNJY0118B, DYNJY0119, DYNJY0121, DYNJY0130A, DYNJY0131A, DYNJY0135, DYNJY0141A, DYNJY0144, DYNJY0150A, DYNJY0151A, DYNJY0152A, DYNJY0153, DYNJY0162B, DYNJY0166A, DYNJY0167A, DYNJY0168, DYNJY0169, DYNJY0173B, DYNJY0179B, DYNJY0181B, DYNJY0183B, DYNJY0184B, DYNJY0186A, DYNJY0195A, DYNJY0203C, DYNJY0207B, DYNJY0210, DYNJY0216, DYNJY0217A, DYNJY0218A, DYNJY0220, DYNJY0221, DYNJY0222, DYNJY0225, DYNJY0227, DYNJY0228, DYNJY0236, DYNJY0238A, DYNJY0239, DYNJY0240, DYNJY0241, DYNJY0244B, DYNJY0246, DYNJY0247, DYNJY0254A, DYNJY0276, DYNJY0277
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, Inc., Mundelein, IL 60060;
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Medline Industries, Inc., 1170 S Northpoint Blvd, Waukegan IL 60085-6757
  • Source
    USFDA