Medline Industries, Inc.: 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;

Recall number

Z-0554-05

Recalling firm

Medline Industries, Inc.

Product

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;

Status

Terminated

Initiated

2005-03-04

Posted

2005-03-11

Terminated

2006-05-25

Reason

There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.

Root cause

Other

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.

Quantity

31,497 cases

Distribution

Nationwide

Lot, serial or model codes

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, 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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, DYNJC2758J DYNJC2759I , 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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

Firm FEI

3000717925

Firm city

Waukegan

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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