Recall of Device Recall Medline Custom Sterile Surgical Packs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31315
  • Event Risk Class
    Class 2
  • Event Number
    Z-0554-05
  • Event Initiated Date
    2005-03-04
  • Event Date Posted
    2005-03-11
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2006-05-25
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    General Surgery Tray - Product Code LRO
  • Reason
    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

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    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

  • Manufacturer Address
    Medline Industries, Inc., 1170 S Northpoint Blvd, Waukegan IL 60085-6757
  • Source
    USFDA