• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 3 Liter LatexFree Breathing Bag

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall 3 Liter LatexFree Breathing Bag see related information
Date Initiated by Firm December 07, 2007
Date Posted June 25, 2008
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-1163-2008
Recall Event ID 46280
Product Classification Reservoir Bag - Product Code BTC
Product 3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number DYNJ09422, Anesthesia Kit-LF; 2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand; 3) Item Number 00-GS2675K, Pacemaker Kit; 4) Item Number ACC010004A, Anesthesia Drawer 6; 5) Item Number ACC010015, Anesthesia Drawer 8; 6) Item Number ACC010015A, Anesthesia Drawer 8; 7) Item Number ACC010031, Anesthesia Case Cart Drawer 6; 8) Item Number ACC010036, Anesthesia Drawer 6; 9) Item Number ACC010056, Anesthesia Cart Drawer 6; 10) Item Number CDS760048M, D&C CDS; 11) Item Number CDS760050L, Vag Hyster CDS; 12) Item Number CDS760054F, Laparoscopy CDS; 13) Item Number CDS780080J, Major Spinal CDS; 14) Item Number CDS780081G, Minor Spine CDS-LF; 15) Item Number CDS780127C, Lumbar CDS; 16) Item Number CDS780150A, Craniotomy CDS-LF; 17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF; 18) Item Number CDS840144B, Open Heart CDS; 19) Item Number CDS840270C, Carotid CDS; 20) Item Number CDS840325B, Major Vascular CDS; 21) Item Number CDS840336A, Heart-LF; 22) Item Number CDS840337A, Vascular Minor CDS-LF; 23) Item Number CDS840338A, Carotid Endarectomy CDS-LF; 24) Item Number CDS840384A, Open Heart CDS; 25) Item Number CDS840429, Arrowhead Open Heart CDS; 26) Item Number CDS840463A, Accessory Pack; 27) Item Number CDS840494, AV Fistula CDS; 28) Item Number CDS860094C, Laparoscopic Colon Resection; 29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF; 30) Item Number CDS860159, Major ABD Procedure CDS-Pack A; 31) Item Number CDS860159A, Major ABD Procedure CDS; 32) Item Number CDS860160A, Minor ABD Procedure CDS; 33) Item Number CDS860161, Lithotomy Major CDS; 34) Item Number CDS860161A, Lithotomy Major CDS; 35) Item Number CDS860200, Lap Appy Kit; 36) Item Number CDS860200A, Lap Appy Kit; 37) Item Number CDS860201, Lap Chole Kit; 38) Item Number CDS860201A, Lap Chole Kit; 39) Item Number CDS860202, Lap Nissen Kit; 40) Item Number CDS860202A, Lap Nissen Kit; 41) Item Number CDS920108C, Laparoscopy CDS; 42) Item Number CDS930145C, Lap Chole CDS; 43) Item Number CDS930178F, Lap Chole Somc CDS-LF; 44) Item Number CDS930183A, Lap Chole CDS-LF; 45) Item Number CDS930208B, Lap Chole CDS; 46) Item Number CDS940836B, Shoulder CDS; 47) Item Number CDS940836C, Shoulder CDS; 48) Item Number CDS940837B, Knee CDS; 49) Item Number CDS940844C, Shoulder Arthroscopy CDS; 50) Item Number CDS940859C, Arthroscopy CDS-LF; 51) Item Number CDS940896F, Arthroscopy CDS; 52) Item Number CDS940900F, Shoulder CDS; 53) Item Number CDS941067A, Knee Replacement Total-LF; 54) Item Number CDS941068B, Total Hip CDS-LF; 55) Item Number CDS941248, Extremity Ortho CDS; 56) Item Number CDS941248A, Extremity Ortho CDS; 57) Item Number CDS941325, Dr Zeegan Total Hip Encino; 58) Item Number CDS941326, Dr Zeegan Total Hip Encino; 59) Item Number CDS980153B, Basic CDS; 60) Item Number CDS980211C, O.R. Turnover Kit; 61) Item Number CDS980228K, Breast Biopsy CDS; 62) Item Number CDS980232L, Plastic CDS; 63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF; 64) Item Number CDS980510D, Neuro Associates Laminectomy; 65) Item Number CDS980701, Shoulder Arthroscopy Procedure; 66) Item Number CDS980702, Knee Arthroscopy Procedure; 67) Item Number CDS980703, Extremity Procedure; 68) Item Number CDS980704, Spine Procedure; 69) Item Number CDS980749, Minor CDS; 70) Item Number CDS980794, Lithotomy CDS; 71) Item Number CDS980796, Knee Arthroscopy CDS; 72) Item Number CDS980797, Gyn Abd CDS; 73) Item Number CDS980798, C-Section CDS; 74) Item Number CDS980799, Lap Chole CDS; 75) Item Number CDS980800, Hand CDS-Dr Casey; 76) Item Number CDS980801A, Lap Gastric CDS; 77) Item Number CDS980817, Total Hip CDS; 78) Item Number CDS980818, AV Fistula CDS; 79) Item Number CDS980819, Knee Arthroscopy CDS; 80) Item Number CDS980820, Shoulder Arthroscopy CDS; 81) Item Number CDS980821
Code Information 3 liter bag, Vendor Part Number: 720057B, Medline Item Number: 40053, all lots manufactured after October 2006, packaged in the following kits: 1) Item Number DYNJ09422, Lot Number(s): 07AD2431, 07ED1171, 07FD0986 and 07GD2699; 2) Item Number DYNJAA9010A, Lot Number(s): 06KD0470, 06LD3329, 07AD3822, 07AD4358 and 07HD3295; 3) Item Number 00-GS2675K, Lot Number(s): 07ID2989; 4) Item Number ACC010004A, Lot Number(s): 07HD1850; 5) Item Number ACC010015, Lot Number(s): 07ED3319 and 07GD1409; 6) Item Number ACC010015A, Lot Number(s): 07ID2781; 7) Item Number ACC010031, Lot Number(s): 07ID3356; 8) Item Number ACC010036, Lot Number(s): 07GD3908; 9) Item Number ACC010056, Lot Number(s): 07JD0955; 10) Item Number CDS760048M, Lot Number(s): 07IB2033; 11) Item Number CDS760050L, Lot Number(s): 07HB0383; 12) Item Number CDS760054F, Lot Number(s): 07HD0309; 13) Item Number CDS780080J, Lot Number(s): 07ID3376; 14) Item Number CDS780081G, Lot Number(s): 07HD2880; 15) Item Number CDS780127C, Lot Number(s): 07AD4385, 07DD3000, 07EB2335 and 07FB0786; 16) Item Number CDS780150A, Lot Number(s): 07BD1234, 07ED3375, 07FB2636, 07HB0382, 07HB1155 and 07HB2927; 17) Item Number CDS780151A, Lot Number(s): 07BD4019, 07CD2926, 07FD1473, 07GB1293 and 07IB3415; 18) Item Number CDS840144B, Lot Number(s): 07CD2326; 19) Item Number CDS840270C, Lot Number(s): 07CD2354; 20) Item Number CDS840325B, Lot Number(s): 07BD1712; 21) Item Number CDS840336A, Lot Number(s): 07AD3267, 07GD3398, 07HB0377, 07HB1614 and 07IB2544; 22) Item Number CDS840337A, Lot Number(s): 07AD4393, 07EB1526 and 07HB2822; 23) Item Number CDS840338A, Lot Number(s): 07BD1721, 07EB1377, 07EB2694 and 07JB0441; 24) Item Number CDS840384A, Lot Number(s): 07BB2640, 07EB1713, 07HB3147 and 07IB0469; 25) Item Number CDS840429, Lot Number(s): 07FB2624, 07GB3695 and 07IB2392; 26) Item Number CDS840463A, Lot Number(s): 07JD1168; 27) Item Number CDS840494, Lot Number(s): 07JD1170; 28) Item Number CDS860094C, Lot Number(s): 07HD2053; 29) Item Number CDS860109A, Lot Number(s): 07GB0028, 07HB1342, 07HB2825 and 07IB1735; 30) Item Number CDS860159, Lot Number(s): 07BD0203 and 07CD3891 31) Item Number CDS860159A, Lot Number(s): 07EB0667, 07FB2140, 07GB2805 and 07HB2823; 32) Item Number CDS860160A, Lot Number(s): 07GB1298; 33) Item Number CDS860161, Lot Number(s): 07AD2448, 07BD2109 and 07CD3361; 34) Item Number CDS860161A, Lot Number(s): 07EB0665, 07FB2520 and 07IB2854; 35) Item Number CDS860200, Lot Number(s): 07CB0292 and 07GB1777; 36) Item Number CDS860200A, Lot Number(s): 07HB3748; 37) Item Number CDS860201, Lot Number(s): 07CB0971, 07GB0032 and 07HB3327; 38) Item Number CDS860201A, Lot Number(s): 07IB2695 and 07IB3323 39) Item Number CDS860202, Lot Number(s): 07CB0724; 40) Item Number CDS860202A, Lot Number(s): 07IB2397; 41) Item Number CDS920108C, Lot Number(s): 07IB2040; 42) Item Number CDS930145C, Lot Number(s): 07BD0419 and 07BD1236; 43) Item Number CDS930178F, Lot Number(s): 07HD3194; 44) Item Number CDS930183A, Lot Number(s): 07ED2055, 07FB2141, 07GB1198, 07HB0185 and 07IB0688; 45) Item Number CDS930208B, Lot Number(s): 07HD2395, 07HD2894, 07ID0410, 07ID1525 and 07ID3717; 46) Item Number CDS940836B, Lot Number(s): 07BB0310, 07BB2177, 07DB1981 and 07FB0922; 47) Item Number CDS940836C, Lot Number(s): 07HB2928; 48) Item Number CDS940837B, Lot Number(s): 07BB0816, 07CB1831, 07EB2017, 07GB2618, 07IB2042 and 07JB1297; 49) Item Number CDS940844C, Lot Number(s): 07HD0758; 50) Item Number CDS940859C, Lot Number(s): 07ID1408; 51) Item Number CDS940896F, Lot Number(s): 07HB2923 and 07IB2386 52) Item Number CDS940900F, Lot Number(s): 07HB2830 and 07JB0623 53) Item Number CDS941067A, Lot Number(s): 07AD3293, 07GB3699 and 07IB3416; 54) Item Number CDS941068B, Lot Number(s): 07BD4018, 07CD2932, 07EB2149, 07FB2398 and 07HB0187; 55) Item Number CDS941248, Lot Number(s): 07BD0238; 56) Item Number CDS941248A, Lot Number(s): 07FB0011, 07GB0862 and 07HB2926; 57) Item Number CDS941325, Lot Number(s): 07AB2984, 07DB1789 and 07EB0575; 58) Item Number CDS941326, Lot Number(s): 07AB3152 and 07DB1429; 59) Item Number CDS980153B, Lot Number(s): 07GD2828 and 07ID3811; 60) Item Number CDS980211C, Lot Number(s): 07BB2436, 07EB0679, 07FB0908, 07GB2130, 07IB0877 and 07IB2043; 61) Item Number CDS980228K, Lot Number(s): 07JB0431; 62) Item Number CDS980232L, Lot Number(s): 07JB0875; 63) Item Number CDS980395, Lot Number(s): 07FB0342, 07GB0023 and 07HB2936; 64) Item Number CDS980510D, Lot Number(s): 07JG0038; 65) Item Number CDS980701, Lot Number(s): 07GB1780 and 07HB1153; 66) Item Number CDS980702, Lot Number(s): 07GB1908; 67) Item Number CDS980703, Lot Number(s): 07FB2626, 07HB2824 and 07HB3284; 68) Item Number CDS980704, Lot Number(s): 07GB2450 and 07JB1024 69) Item Number CDS980749, Lot Number(s): 07JD0762 and 07JD1353; 70) Item Number CDS980794, Lot Number(s): 07GG1799; 71) Item Number CDS980796, Lot Number(s): 07HG0901; 72) Item Number CDS980797, Lot Number(s): 07HG0336; 73) Item Number CDS980798, Lot Number(s): 07HG0424; 74) Item Number CDS980799, Lot Number(s): 07HG0426 and 07HG0678; 75) Item Number CDS980800, Lot Number(s): 07HB3544; 76) Item Number CDS980801A, Lot Number(s): 07HB2940; 77) Item Number CDS980817, Lot Number(s): 07ID3858; 78) Item Number CDS980818, Lot Number(s): 07ID2696; 79) Item Number CDS980819, Lot Number(s): 07ID2697; 80) Item Number CDS980820, Lot Number(s): 07ID2698; 81) Item Number CDS980821, Lot Number(s): 07ID2699; 82) Item Number CDS980822, Lot Number(s): 07ID3857; 83) Item Number CDS980823, Lot Number(s): 07ID2700; 84) Item Number CDS980831, Lot Number(s): 07HB3758; 85) Item Number CDS980846, Lot Number(s): 07IB2156 and 07IB3031; 86) Item Number CDS980847, Lot Number(s): 07IB2155 and 07JB1326; 87) Item Number CDS980848, Lot Number(s): 07ID2895; 88) Item Number CDS980849, Lot Number(s): 07ID2892; 89) Item Number CDS980850, Lot Number(s): 07ID2893; 90) Item Number CDS980851, Lot Number(s): 07ID2894; 91) Item Number CDS980904, Lot Number(s): 7JD1193; 92) Item Number CMPJ21747A, Lot Number(s): 07CD3683; 93) Item Number CMPJY0146D, Lot Number(s): 07JD0233; 94) Item Number DYNJAA0063, Lot Number(s): 07BD1218, 07FD2268 and 07GD3483; 95) Item Number DYNJAA0261B, Lot Number(s): 07HD3458; 96) Item Number DYNJAA0266A, Lot Number(s): 07BD0007, 07CD3097, 07FD0995, 07GD3474 and 07JD0008; 97) Item Number DYNJAA0283B, Lot Number(s): 07DD2175, 07GD2614, 07ID2910 and 07JB0510; 98) Item Number DYNJAA4751, Lot Number(s): 07FD1245; 99) Item Number DYNJAA4755A, Lot Number(s): 06JD1180; 100) Item Number DYNJAA4757A, Lot Number(s): 06JD3969, 06LD0329, 07AD3249, 07CD2866, 07FD1850, 07GD3141 and 07ID3529; 101) Item Number DYNJAA4761, Lot Number(s): 07ED3321, 07HD2674 and 07JB0815; 102) Item Number DYNJAA4765C, Lot Number(s): 07HD3543; 103) Item Number DYNJAA4774, Lot Number(s): 07IB3301, 07AD3250, 07FD1249 and 07GD3473; 104) Item Number DYNJAA4776A, Lot Number(s): 07ID0143 105) Item Number DYNJAA4778, Lot Number(s): 07JB0818, 07DD1385, 07GD1823 and 07ID2682; 106) Item Number DYNJAA4791A, Lot Number(s): 06KD1613, 07AD1653, 07FD1363, 07HD0086 and 07JD0392; 107) Item Number DYNJAA4792, Lot Number(s): 07JB0819, 07ED3324 and 07GD2939; 108) Item Number DYNJAA4798, Lot Number(s): 07JB1563, 07FD0991, 07FD2266 and 07ID2691; 109) Item Number DYNJAA4805, Lot Number(s): 07CD4296, 07FD1247 and 07GD3573; 110) Item Number DYNJAA4808, Lot Number(s): 07DD2013 and 07DD2013Z; 111) Item Number DYNJAA4808A, Lot Number(s): 07JB0475 and 07GD3595; 112) Item Number DYNJAA4809, Lot Number(s): 07CD3606, 07DD3012, 07ED3339 and 07GD1601; 113) Item Number DYNJAA4809A, Lot Number(s): 07HD2208 and 07JD1189; 114) Item Number DYNJAA4811A, Lot Number(s): 07HD3460; 115) Item Number DYNJAA4812, Lot Number(s): 07FD1852, 07HD4223 and 07JD0947; 116) Item Number DYNJAA4815, Lot Number(s): 07GD1570 and 07ID0400; 117) Item Number DYNJAA4816, Lot Number(s): 07JB1109 and 07HD2035; 118) Item Number DYNJAA4817, Lot Number(s): 07HD2542; 119) Item Number DYNJAA4819, Lot Number(s): 07ID3545; 120) Item Number DYNJAA4820, Lot Number(s): 07ID3132; 121) Item Number DYNJAA4821, Lot Number(s): 07ID3133; 122) Item Number DYNJAA4828, Lot Number(s): 07ID3566; 123) Item Number DYNJAA6420B, Lot Number(s): 07BD1213, 07CD3099, 07FD1853 and 07ID2690; 124) Item Number DYNJAA6445, Lot Number(s): 06KD1164, 07AD2804, 07ED3419, 07FD2065, 07GD1811 and 07ID3544; 125) Item Number DYNJAA6453, Lot Number(s): 06JD3029, 07BD3638, 07CD3860, 07FD0992, 07HD0227 and 07JD0013; 126) Item Number DYNJAA6459A, Lot Number(s): 07GD1321 and 07ID2684; 127) Item Number DYNJAA6461B, Lot Number(s): 07BD0562, 07CD4301, 07FD2267, 07GD1509, 07HD2211 and 07JB1650; 128) Item Number DYNJAA6474, Lot Number(s): 06JD3397, 07BD3634, 07GD1830, 07HD2654, 07HD4142 and 07ID0705; 129) Item Number DYNJAA6475, Lot Number(s): 06JD0389, 06LD2328, 07AD3246, 07CD1502Z, 07DD0723, 07ED3328, 07FD1856, 07HD3287 and 07JD0745; 130) Item Number DYNJAA6483, Lot Number(s): 07FD1846, 07GD1843, 07HD2647 and 07ID2666; 131) Item Number DYNJAA6485A, Lot Number(s): 07GD3936, 07HD2036 and 07ID4039; 132) Item Number DYNJAA6486, Lot Number(s): 07HD0572; 133) Item Number DYNJAA6489, Lot Number(s): 07ID3824; 134) Item Number DYNJAA6490, Lot Number(s): 07JD0595; 135) Item Number DYNJAA9010A, Lot Number(s): 06KD0470, 06LD3329, 07AD3822, 07AD4358 and 07HD3295; 136) Item Number DYNJAA9040, Lot Number(s): 07AD3240, 07CD3101 and 07DD2177; 137) Item Number DYNJAA9700B, Lot Number(s): 07DD1140, 07GD2265, 07HD0692 and 07ID3879; 138) Item Number DYNJAA9714C, Lot Number(s): 07ED3325, 07GD1511 and 07HD3481; 139) Item Number DYNJAA9717, Lot Number(s): 07ED3329, 07GD2196 and 07ID2683; 140) Item Number DYNJAA9724A, Lot Number(s): 07JB0816, 07BD0292, 07FD1412 and 07HD4093; 141) Item Number DYNJAA9726, Lot Number(s): 07AD4482, 07CD2681, 07ED3543, 07FD0971, 07HD2212 and 07ID3883; 142) Item Number DYNJAA9729A, Lot Number(s): 07ED3330, 07HD2213 and 07ID2688; 143) Item Number DYNJAA9748, Lot Number(s): 07DD0241, 07DD0241Z, 07FD1625 and 07GD1837; 144) Item Number DYNJAA9762, Lot Number(s): 07JB0478, 07ED3331 and 07HD3334; 145) Item Number DYNJAA9774A, Lot Number(s): 07AD4951, 07FD1409, 07GD2198 and 07HD4257; 146) Item Number DYNJAA9777C, Lot Number(s): 07GD3594, 07HD0690, 07ID3119 and 07JD0230; 147) Item Number DYNJAA9779, Lot Number(s): 07BD0195, 07BD2655, 07ED3332, 07GD1507 and 07HD4255; 148) Item Number DYNJAA9783, Lot Number(s): 07DD2803 and 07ID3880; 149) Item Number DYNJAA9814, Lot Number(s): 06KD1949, 07AD4956, 07CD4293, 07FD1627, 07HD2037 and 07ID3124; 150) Item Number DYNJAA9819, Lot Number(s): 07BD2651, 07DD2181, 07HD2048 and 07IB2728; 151) Item Number DYNJAA9821, Lot Number(s): 06JD4351; 152) Item Number DYNJAA9833, Lot Number(s): 07BD3652, 07DD0227, 07FD1248, 07HD3316 and 07ID3878; 153) Item Number DYNJAA9834, Lot Number(s): 07DD0228, 07DD0228Z, 07GD1542 and 07HD3315; 154) Item Number DYNJAA9835B, Lot Number(s): 07AD4084, 07ED3322, 07FD1858 and 07ID2692; 155) Item Number DYNJAA9836, Lot Number(s): 07AD3251, 07AD4952, 07ED3320, 07FD2072, 07HD2049 and 07ID2909; 156) Item Number DYNJAA9837, Lot Number(s): 07DD0726, 07FD0993, 07GD3476 and 07JD0203; 157) Item Number DYNJAA9840, Lot Number(s): 07DD0239, 07DD0239Z, 07GD1869 and 07ID3382; 158) Item Number DYNJAA9842, Lot Number(s): 07BD3943, 07CD3102 and 07HD2047; 159) Item Number DYNJAA9844B, Lot Number(s): 07AD3253, 07BD3123, 07CD3103, 07FD0987, 07GD1600, 07HD2050, 07HD2922, 07ID2934 and 07JD0781; 160) Item Number DYNJAA9845, Lot Number(s): 07CD3623, 07GD2195 and 07JD0015; 161) Item Number DYNJAA9864A, Lot Number(s): 07BD2911, 07DD0495, 07GD2283, 07ID2908 and 07JB0842; 162) Item Number DYNJAA9865, Lot Number(s): 07BD3257, 07ED3326, 07GD2670 and 07JD1188; 163) Item Number DYNJAA9871, Lot Number(s): 07BD0553, 07BD2637, 07CD3863 and 07HD0081; 164) Item Number DYNJAA9874, Lot Number(s): 07DD0694, 07GD1508 and 07ID3882; 165) Item Number DYNJAA9879, Lot Number(s): 07JB0820, 07GD1308 and 07HD2408; 166) Item Number DYNJAA9880, Lot Number(s): 07BD0559, 07FD1845, 07GD3938 and 07ID3117; 167) Item Number DYNJAA9884, Lot Number(s): 07JB0503, 07BD3945, 07CD4294, 07FD0972, 07GD2668 and 07ID2687; 168) Item Number DYNJAA9888, Lot Number(s): 07BD2490, 07DD0684, 07FD1243, 07GD2930 and 07JD0942; 169) Item Number DYNJAA9889B, Lot Number(s): 07ID0134; 170) Item Number DYNJAA9890, Lot Number(s): 07BD0189, 07CD2682, 07FD1859 and 07HD4256; 171) Item Number DYNJAA9894, Lot Number(s): 07BD2306; 172) Item Number DYNJAA9898, Lot Number(s): 07FD0970, 07GD1510, 07GD3937 and 07ID2686; 173) Item Number DYNJAA9899, Lot Number(s): 07BD2907, 07FD1860, 07HD0578 and 07ID3565; 174) Item Number DYNJAA9900, Lot Number(s): 07FD1246; 175) Item Number DYNJAA9900B, Lot Number(s): 07IB3073; 176) Item Number DYNJAA9902, Lot Number(s): 07DD2343, 07FD0973, 07GD1490, 07HD0577, 07ID3094 and 07JD0946; 177) Item Number DYNJAA9903, Lot Number(s): 07CD3620, 07GD1506 and 07ID3125; 178) Item Number DYNJAA9905, Lot Number(s): 07ED3323, 07GD3571 and 07JD0778; 179) Item Number DYNJAA9907, Lot Number(s): 07GD1370; 180) Item Number DYNJAA9915, Lot Number(s): 07FD1861; 181) Item Number DYNJAA9918, Lot Number(s): 07GD2288; 182) Item Number DYNJAA9919, Lot Number(s): 07GD1599 and 07ID0405; 183) Item Number DYNJAA9920, Lot Number(s): 07GD1598 and 07ID3531; 184) Item Number DYNJAA9921, Lot Number(s): 07HD1779 and 07JD0958; 185) Item Number DYNJAA9924, Lot Number(s): 07HD1793; 186) Item Number DYNJAA9925, Lot Number(s): 07HD2215; 187) Item Number DYNJAA9927, Lot Number(s): 07ID2681; 188) Item Number DYNJAA9928, Lot Number(s): 07ID0371; 189) Item Number DYNJAA9930, Lot Number(s): 07ID2680; 190) Item Number DYNJAA9931, Lot Number(s): 07JD0364; 191) Item Number DYNJAAF6258A, Lot Number(s): 07BD2652, 07DD0242, 07FD0994, 07GD2201 and 07ID2689; 192) Item Number DYNJAAF6262, Lot Number(s): 07BD1511, 07DD0240, 07ED3544, 07FD1410, 07GD2938, 07HD3304 and 07ID3538; 193) Item Number DYNJAAF6288A, Lot Number(s): 06JD2484, 06LD2319, 07DD0709, 07GD1498 and 07HD3552; 194) Item Number DYNJAAF6293, Lot Number(s): 07IB2810, 07BD2650, 07ED3327, 07GD1543 and 07HD3871; 195) Item Number DYNJAAF6295, Lot Number(s): 07BD2915; 196) Item Number DYNJAAF6297A, Lot Number(s): 06KD0463, 06LD3452, 07AD4085, 07FD1406 and 07GD3142; 197) Item Number DYNJAAF6298A, Lot Number(s): 07IB3086, 06JD3221, 06LD0318, 07CD4297, 07GD2194, 07HD3480 and 07ID3741; 198) Item Number DYNJAAF6302, Lot Number(s): 07FD1844, 07GD3572 and 07ID2685; 199) Item Number DYNJAAF6324, Lot Number(s): 07BD3422, 07CD3540, 07FD2069 and 07HD4247; 200) Item Number DYNJAAF6326, Lot Number(s): 07CD2879, 07CD3617, 07FD0974, 07FD1848, 07GD3260, 07HD0922, 07ID3091 and 07JD0933; 201) Item Number DYNJAAF6327, Lot Number(s): 07ID3089; 202) Item Number DYNJAAF6329, Lot Number(s): 07DD1133, 07ED3333 and 07GD3794; 203) Item Number DYNJAAF6330, Lot Number(s): 07DD1125, 07GD1863 and 07ID1104; 204) Item Number DYNJAAF6331, Lot Number(s): 07FD1244 and 07HD4285; 205) Item Number DYNJAAF6341, Lot Number(s): 07HD2038 and 07ID3093; 206) Item Number DYNJAAF6342, Lot Number(s): 07GD1337 and 07GD2157; 207) Item Number DYNJAAF6343, Lot Number(s): 07HD0226 and 07ID3807; 208) Item Number DYNJAAF6344, Lot Number(s): 07HD3162; 209) Item Number DYNJAAF6345, Lot Number(s): 07ID0138; 210) Item Number DYNJAAF6346, Lot Number(s): 07JD0231; 211) Item Number DYNJAAHY13, Lot Number(s): 06JD2830, 07AD1669, 07CD2886, 07FD1420, 07HD0675 and 07ID1346; 212) Item Number DYNJAAHY14, Lot Number(s): 06KD3560; 213) Item Number DYNJT2590, Lot Number(s): 07JB0017; 214) Item Number DYNJT2591A, Lot Number(s): 07JB0632  
Recalling Firm/
Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact
Manufacturer Reason
for Recall
Separation from Bushing: The breathing bag may separate from the bushing during use.
FDA Determined
Cause 2
Device Design
Action Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.
Quantity in Commerce 436,750 bags
Distribution Nationwide Distribution.
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.