Ethicon, Inc.

Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution -- US (nationwide) and Canada.

Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. || Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.

TC003 (US Only) TC013 (US Only) TC033 (OUS Only) TC043 (OUS Only).   Code, Batch: TC04320, GMMG07; TC00320, GMMG08; TC00320, GMMG09; TC00320, GMMG10; TC04320, GMMG11; TC03320, GPMG01; TC04320, GPMG02; TC00320, GPMG03; TC00320, GPMG04; TC00320, GPMG05; TC01320, GPMG06; TC04320, GPMG07; TC03320, GPMG08; TC04320, GPMG09; TC00320, GPMG10; TC00320, GPMG11; TC00320, HAMG01; TC00320, HAMG02; TC03320, HAMG03; TC04320, HAMG04; TC00320, HAMG05; TC00320, HAMG06; TC00320, HAMG07; TC00320, HAMG08; TC01320, HAMG09; TC03320, HAMG10; TC04320, HAMG11; TC04320, HAMG12; TC00320, HAMG13; TC00320, HAMG14; TC00320, HBMG01; TC00320, HBMG02; TC04320, HBMG03; TC04320, HBMG04; TC03320, HBMG05; TC00320, HBMG06; TC00320, HBMG07; TC04320, HBMG08; TC03320, HBMG09; TC00320, HBMG10; TC00320, HCMG01; TC00320, HCMG02; TC00320, HCMG03; TC00320, HCMG04; TC04320, HCMG05; TC04320, HCMG06; TC03320, HDMG01; TC00320, HDMG02; TC00320, HDMG03; TC00320, HDMG04; TC00320, HDMG05; TC03320, HEMG01; TC04320, HEMG02; TC01320, HEMG03; TC00320, HEMG05; TC00320, HEMG06; TC00320, HEMG07; TC00320, HEMG08; TC04320, HEMG09; TC04320, HGMG01; TC03320, HGMG02; TC00320, HGMG03; TC00320, HGMG04; TC00320, HGMG05; TC00320, HGMG06; TC00320, HGMG07; TC04320, HGMG08; TC04320, HGMG09; TC04320, HGMG10; TC00320, HHMG01; TC00320, HHMG02; TC00320, HHMG03; TC00320, HHMG04; TC03320, HHMG05; TC04320, HHMG06; TC00320, HHMG08; TC00320, HHMG09; TC00320, HHMG10; TC04320, HHMG07; TC00320, HHMG11; TC00320, HHMG12; TC00320, HJMG02; TC00320, HJMG03; TC00320, HJMG04; TC00320, HJMG05; TC00320, HJMG06; TC01320, HJMG07; TC03320, HJMG08; TC04320, HJMG09; TC04320, HJMG10; TC00320, HJMG11; TC00320, HJMG12; TC00320, HJMG13; TC04320, HKMG01; TC00320, HJMG14; TC04320, HKMG02; TC03320, HKMG03; TC00320, HKMG04; TC00320, HKMG05; TC00320, HKMG06; TC04320, HKMG07; TC03320, HKMG08; TC00320, HKMG10; TC00320, HKMG09; TC00320, HKMG11; TC00320, HLMG01; TC00320, HLMG02; TC00320, HLMG03; TC01320, HLMG04; TC04320, HLMG05; TC03320, HLMG06; TC00320, HLMG07; TC00320, HLMG08; TC00320, HLMG09; TC04320, HLMG10; TC03320, HMMG01; TC04320, HMMG02; TC00320, HMMG03; TC00320, HMMG04; TC04320, HMMG05; TC00320, HMMG06; TC00320, HMMG07; TC00320, HPMG01; TC00320, HPMG02; TC04320, HPMG04; TC03320, HPMG03; TC04320, HPMG05; TC00320, HPMG06; TC00320, HPMG07; TC00320, JAMG01; TC00320, JAMG02; TC04320, JAMG03; TC00320, JAMG05; TC00320, JAMG04; TC01320, JAMG06; TC00320, JAMG07; TC04320, JAMG08; TC00320, JAMG10; TC03320, JAMG09; TC00320, JAMG11; TC00320, JBMG01; TC04320, JBMG02; TC04320, JBMG03; TC03320, JBMG04; TC00320, JBMG05; TC00320, JBMG06; TC00320, JBMG07; TC04320, JBMG08; TC00320, JBMG09; TC00320, JBMG10; TC00320, JBMG11; TC04320, JCMG01; TC03320, JCMG02; TC00320, JCMG03; TC00320, JCMG04; TC01320, JCMG05; TC04320, JDMG01; TC00320, JDMG02; TC00320, JDMG03; TC00320, JDMG04; TC04320, JDMG05; TC00320, JDMG06; TC04320, JDMG07; TC00320, JEMG01; TC00320, JEMG02; TC00320, JEMG03; TC00320, JEMG04; TC03320, JEMG05; TC00320, JGMG02; TC04320, JGMG03; TC03320, JGMG04; TC00320, JGMG05; TC00320, JGMG09; TC04320, JGMG10; TC04313, JGMG14; TC04320, JGMG15; TC00320, JGMG16; TC03320, JGMG17; TC00320, JGMG18; TC00320, JHMG02; TC04320, JHMG05; TC00320, JHMG03; TC04320, JHMG04; TC00320, JHMG06; TC00320, JHMG07; TC00320, JHMG08; TC00320, JHMG09; TC00320, JHMG10; TC04320, JHMG11; TC00320, JHMG12; TC03320, JJMG01; TC00320, JJMG02; TC00320, JJMG04; TC00320, JJMG05; TC01320, JJMG06; TC00320, JJMG07; TC03313, JJMG08; TC00320, JJMG09; TC04313, JKMG02; TC00320, JKMG01; TC03313, JKMG03; TC00320, JKMG04; TC00320, JKMG05; TC00320, JKMG06; TC00320, JKMG08; TC04313, JLMG01; TC00320, JLMG02; TC00320, JLMG04; TC03313, JLMG05; and TC00320, JLMG06. As of 1/8/2016, 5 Additional lots (US Only - JKMG01, JKMG04 and JKMG05; OUS Only - JKMG02 and JKMG03) were found to be affected by this field action.

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. || The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Product Code -- Lot: PCDD1---- UHG068; UJG096; UJG110; UJG131; UJG149; UKG264; ULG335; ULG316; ULG313; ULG342; ULG374; ULG385; ULG409; UMG490; UMG492; UMG004; UHG038; UHG025; UHG021;   PCDM1 ---- UJG078; UJG082; UJG085; UJG087; UJG109; ULG103; ULG101; ULG095; ULG125; UJG128; ULG139; UJG142; UKG184; UKG183; UKG181; UKG175; UKG161; UKG187; UKG203; UKG201; UEG883; UKG231; UKG239; UKG241; UKG279; UKG253;  UKG250; UKG243; UKG267; UKG266; UKG256; ULG309; ULG287; ULG328; ULG311; ULG370; ULG369; ULG340; ULG337; ULG393; ULG399; ULG400; ULG373; ULG401; ULG405; UMG424; UMG425; UMG426; UMG448; UMG449; UMG479; UMG478; UMG477; UMG473; UMG450; UMG504; UMG486; UGG001; UGG999; UHG014; UHG040; UHG031; UHG026;   PCDN1 ----- UHG056; UHG059; UHG072; UHG054; UJG075; UJG077; UJG088; UJG092; UJG099; UJG107; UJG134; UJG129; UJG122; UJG144; UJG154; UJG156; UJG160; UKG176; UKG170; UKG169; UKG166; UKG177; UKG190; UKG198; UKG215; UKG213; UKG220; UKG222; UKG225; UKG233; UKG248; UKG260; ULG308; ULG305; ULG289; ULG285; ULG281; ULG278; ULG272; ULG271; ULG269; ULG331; ULG321; ULG317; ULG315; ULG344; ULG343; ULG346; ULG352; ULG371; ULG368; ULG365; ULG361; ULG359; ULG341; ULG390; ULG392; ULG394; ULG396; UMG432; UMG427; ULG413; UMG438; UMG445; UMG472; UMG471; UMG459; UMG456; UMG455; UMG476; UMG493; UMG505; UMG509; UHG005; UHG019; UHG022; UHG034; UHG043; UHG044;    PCDL1 ----- UMG489; UMG483; UMG468; UMG451; UMG431; ULG408; UMG429; UMG430; ULG398; ULG397; ULG381; ULG339; ULG354; ULG355; ULG306; ULG319; ULG332; ULG193; ULG298; ULG279; ULG275; UKG255; UKG229; UKG227; UKG226; UKG168; UKG173; UKG178; UJG117; UJG094; UHG053; UHG069; UJG080; UHG060; UJG073; UHG048;   PCDH1 ----- UMG475; UMG481; UMG494; UMG436; UMG437; UMG454; UMG458; UMG457; UMG423; UMG433; UMG414; UMG415; ULG375; ULG376; ULG377; ULG391; ULG406; ULG372; ULG349; ULG348; ULG336; ULG327; ULG310; ULG304; ULG300; ULG288; ULG276; UKG265; UKG252; UKG218; UKG219; UKG230; UKG217; UKG205; UKG204; UKG186; UKG174; UKG167; UKG163; UJG157; UJG145; UJG143; UJG141; UJG127; UJG100; UJG098; UJG115; UJG114; UJG108; UJG084; UGG997; UGG998; UHG013; UHG030; UHG039;    PCDB1 ------ ULG323; ULG296; UEG886; UEG884; UJG116; UJG108; UJG104; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG323; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG079; UJG089; UHG065; UJG076; UHG067;  PCDG1 ----- UMG482; UMG498; UMG499; UMG500; UMG441; UMG469; UMG470; UMG442; UMG447; UMG446; ULG402; UMG416; UMG419; UMG420; UMG421; UMG422; ULG384; ULG386; ULG387; ULG395; ULG356; ULG366; ULG367; ULG338; ULG329; ULG326; ULG325; ULG274; ULG334; ULG307; ULG299; ULG294; ULG288; ULG284; ULG283; UKG258; UKG259; UKG263; ULG277; UEG885; UKG234; UKG244; UKG245; UKG254; UKG196; UKG210; UKG197; UKG191; UKG193; UKG162; UKG179; UKG180; UJG146; UJG148; UJG153; UJG159; UJG132; UJG130; UJG124; UJG121; UJG105; UJG113; UJG091; UJG086; UJG083; UHG012; UHG063; UHG061; UHG047; UHG071; UHG064; UHG058; UHG055; UHG002; UHG003; UHG011; UHG017; UHG027; UHG036; UHG037; UHG041; UHG042; UHG045;   PCDT1 ----- UMG488; UMG485; UMG491; UMG452; UMG453; UMG435; ULG407; ULG410; UMG417; UMG428; UMG434; ULG363; ULG364; ULG389; ULG345; ULG357; ULG358; ULG291; ULG273; UKG257; UKG236; UKG221; UKG208; UKG209; UKG192; UKG171; UJG137; UJG111; UJG074; UHG057; UHG051; UHG020; UHG032; UHG033; UHG049;   PCDR1 ----- UMG487; UMG502; UMG474; UMG480; ULG333; ULG347; ULG301; ULG290; ULG282; UKG228; UKG237; UKG240; UKG195; UKG172; UJG147; UJG150; UJG140; UJG138; UJG136; UJG123; UJG102; UJG093; UJG090; UHG070; UHG062; UHG046; UHG052; UGG996; UHG006; UHG008; UHG009; UHG010; UHG016; UHG028;   PCDW1 ----- UMG495; UMG496; UMG444; UMG443; ULG412; UMG418; ULG378; ULG388; ULG380; ULG379; ULG360; ULG320; ULG297; ULG292; ULG280; UKG261; UKG251; UKG247; UKG189; UEG887; UKG206; UKG202; UKG188; UJG120; UJG151; UJG133; UHG029; UHG050;   PCDJ1 ------- UMG484; UMG497; UMG439; UMG440; ULG383; ULG382; ULG403; ULG404; ULG362; ULG353; ULG350; ULG351; ULG330; ULG314; ULG312; UKG238; ULG303; ULG318; ULG270; ULG268; UKG262; UKG246; UKG235; UKG232; UKG199; UKG212; UKG211; UKG200; UKG199; UKG185; UKG194; UKG182; UKG165; UKG164; UJG155; UJG152; UJG119; UJG165; UJG118; UJG112; UJG097; UJG081; UHG066; UGG990; UHG007; UHG015; UHG018;

General and Plastic Surgery Devices

2

Yes

There is a total of 1,070 consignees that have received recall product divided between hospitals and distributors nationwide. The product has been distributed internationally to the following countries: Argentina, Australia, Austra, Brazil, Canada, Chile Colombia, Czechoslovakian Republic, France, Germany Greece, Guaynabo, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Republic of Yemen, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirate, United Kingdom, Venezuela. Government shipments include: Alaska Area Native Health, Anchorage, AK; Audie L. Murphy VA Hospital, San Antonio, TX; VA Warehouse, Sioux Falls, SD; VA Medical Center, Miami, FL; Edward Hines Jr. VA Hospital, Hines, IL; J.L. McClellan VA Med. Ctr, Little Rock, AR; Medical Supply Warehouse, Andrews AFB, MD; Mike O''Callaghan Fed. Hospit, Neillis AFB, NV; Naval Medical Ctr., Portsmouth, VA; Recv Officer Hanal Hosp, Jacksonville, FL; USAF Academy Hospital, USAF Academy, CO; USAF Hospital Elmendorf, Elmendorf AFB, AK; VA Bay Pines, Saint Petersburg, FL; VA Hosp. Supply Service, Dallas, TX; VA Louisville, Louisville, KY; VA Med. Center WTS, Indianapolis, IN; VA Med. Ctr., Huntington, WV; VA Med. Ctr., Los Angeles, CA; VA Med. Ctr., Buffalo, NY; VA Med. Ctr., San Juan, PR; VA Med. Ctr, East Orange, NJ; VA Med. Ctr., New York, NY; VA Med. Ctr., Kansas City, MO; VA Med. Ctr., Leavenworth, KS; VA Med. Ctr., Wichita, KS; VA Med. Ctr., Temple, TX; VA Med. Ctr., Amarillo, TX; VA Med. Ctr., Grand Junction, CO; VA Med. Ctr., Nashville, TN; VA Med. Ctr., Mountain Home, TN; VA Med. Ctr., Loma Linda, CA; VA Med. Ctr., Wilmington, DE; VA Med. Ctr., Salisbury, NC; VA Med. Ctr., Columbia, MO; VA Med. Ctr., Saint Louis, MO; VA New York Harbor Healthcare, Brooklyn, NY; WHMC/MSLS, Lackland AFB, TX; Womack Army, Fort Bragg, NC.

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.

All codes.  MH2548, MH2549, MH2550, MH2744, MH2745, MH7477, MH7478, MH7479, MH7481, MH7482, MH7495, MH7636, MH7637, MH7638, MH7703R, MH7708, MH7709, MH7710, MJ2180, MJ2181, MJ2182, MJ2213, MJ2214, MJ2739, MJ2740, MJ2741R, MJ2742R, MJ2743R, MJ2789, MJ7119, MJ7120, MJ7121R, MJ7330, MJ7331, MJ7332, MJ7363, MJ7364, MJ7365, MJ7706, MJ7707, MJ7826, MJ7827, MJ7886, MJ7900R, MJ7901R, MJ7902R, MJ7969, MJ7970, MJ7971, MJ7975, MJ7976, MJ7978, MJ7979, MJ7980, MJ7981, MJ7982, MJ7983, MJ7984, MJ7985, MJ7986, MJ7990, MJ7991, MJ7993, MJ7994, MJ8013, MJ8018, MJ8019, MJ8020R, MJ8021, MJ8022R, MJ8023R, MK2185, MK7186, MK7269, MK7343, MK7344, MK7376, MK7468, MK7469, MK7471, MK7472, MK7473, MK7474, MK7477, MK7478, MK7479, MK7480R, MK7481, MK7482, MK7483, MK7484, MK7486, MK7487, MK7501, MK7502, MK7503, MK7504, MK7505, MK7506, MK7507, MK7564, MK7565, MK7566, MK7567, MK7634, MK7822, MK7824, MK8014, MK8015, MK8016, MK8017, MK8023, MK8024, ML2020, ML2191, ML2941, ML7175R, ML7250, ML7424, ML7430, ML9750, ML9767, MM2056, MM2080, MM2581, MM2797, MM2798, MM2799, MM2800, MM2803, MM2804, MM2807, MM2810, MM7207, MM7589, MM7677, MM9729, MM9740, MM9750, MM9755, MM9891, MM9896, MM9897, MP2094, MP2403, MP2426, MP2474, MP2551, MP2601, MP2602, MP2603, MP2817, MP2840, MP2841, MP7251, MP7252, MP7351, MP7367, MP7644, MP7704, MP7761, MP7828, MP7829, MP7849, MP9702, MP9734, MP9759, MP9762, MP9772, MP9876, MP9916, PA2258, PA2259, PA2260, PA7254, PA7255, PA7256, PA7381, PA7400, PA7700, PA7702, PA7703, PA7742, PA7806, PA7807, PA7924, PA9717, PA9719, PA9729, PA9730, PA9749, PA9771, PA9776, PA9872, PA9873, PA9897, PB2421, PB2473, PB2474, PB2483, PB2545, PB2548, PB2555, PB2672, PB2673, PB2718, PB2755, PB2774, PB2795, PB2838, PB2861, PB2862, PB2874, PB7150, PB7345, PB7346, PB7633, PB7634, PB7637, PB7638, PB7639, PB7640, PB7641, PB7772, PB7773, PB7909, PB7910, PB9711, PB9712, PB9729, PB9739, PB9741, PB9743, PB9887, PB9926, PB9944, PB9951, PB9984, PC2042, PC2043, PC2057, PC2066, PC2104, PC2408, PC2459, PC2471, PC2481, PC2508, PC2509, PC2537, PC2598, PC2805, PC2814, PC2815, PC2829, PC2866, PC2924, PC2925, PC7126, PC7149, PC7323, PC7324, PC7325, PC7326, PC7327, PC7329, PC7392, PC7393, PC7394, PC7395, PC7770, PC7864, PC7904, PC7905, PC9700, PC9717, PC9756, PC9757, PC9776, PC9790, PC9792, PC9793, PC9803, PC9963, PC9966, PC9967, PD2091, PD2092, PD2183, PD2418, PD2420, PD2446, PD2463, PD2480, PD2481, PD2482, PD2494, PD2721, PD2723, PD2772, PD2774, PD2796, PD7290, PD7291, PD7331, PD7428, PD7544, PD7697, PD7698, PD7699, PD7732, PD7745, PD7746, PD7747, PD7767, PD7799, PD7899, PD9711, PD9719, PD9724, PD9725, PD9732, PD9743, PD9754, PD9755, PD9763, PD9766, PD9767, PD9889, PD9899, PD9913, PD9914, PD9933, PE2073, PE2185, PE2435, PE2552, PE2553, PE2558, PE2559, PE2586, PE2587, PE2603, PE2607, PE2612, PE2619, PE2896, PE2896S, PE2980, PE7565, PE7566, PE7567, PE7600, PE7627, PE7685, PE7686, PE7830, PE7879, PE7879S, PE9712, PE9730, PE9742, PE9754, PE9766, PE9817, PE9818, PE9825, PE9830, PG2011S, PG2132, PG2133, PG2159, PG2160, PG2161, PG2413, PG2451, PG2454, PG2456, PG2554, PG2624, PG2625, PG2629, PG2635, PG2636, PG2661, PG2662, PG2663, PG2694, PG2695, PG2702, PG2703, PG2780, PG2977, PG7131, PG7132, PG7383, PG7384, PG7474, PG7475, PG7488, PG7595, PG7620, PG7621, PG7717, PG7754, PG7755, PG7851, PG7852, PG7998, PG9708, PG9710, PG9730, PG9744, PG9748, PG9749, PG9750, PG9753, PG9757, PG9758, PG9849, PG9850, PG9884, PH2015, PH2410, PH2414, PH2423, PH2424, PH2427, PH2428, PH2429, PH2430, PH2431, PH2442, PH2446, PH2447, PH2449, PH2451, PH2477, PH2481, PH2742, PH2747, PH2774, PH2981, PH7180, PH7389, PH7390, PH7407, PH7408, PH9734, PH9735, PH9751, PH9756, PH9886R, PH9903, PJ2036, PJ2036D, PJ2037, PJ2037D, PJ2078, PJ2078D, PJ2220, PJ2221, PJ2413, PJ2418, PJ2419, PJ2420, PJ2422, PJ2430, PJ2478, PJ2479, PJ2484, PJ2485, PJ2500, PJ2505, PJ2508, PJ2631, PJ2650, PJ2650D, PJ2655, PJ2679, PJ2680, PJ2681, PJ2681D, PJ2682, PJ2682D, PJ2749, PJ2749D, PJ2750, PJ7245, PJ7246, PJ7247, PJ7255, PJ7255D, PJ7259, PJ7259D, PJ7440, PJ7549, PJ7577, PJ7578, PJ7584, PJ7584D, PJ7588, PJ7589, PJ7590, PJ7599D, PJ7599S, PJ7600, PJ7600D, PJ7601, PJ7606, PJ7606D, PJ7695, PJ7710, PJ9703, PJ9704D, PJ9704S, PJ9705, PJ9711, PJ9720, PJ9740, PJ9855, PJ9856, PJ9857, PJ9860, PJ9861, PJ9861D, PJ9866, PJ9866D, PJ9867, PJ9901, PJ9902, PK2198, PK2199, PK2244, PK2292, PK2405, PK2407, PK2409, PK2414, PK2441, PK2501, PK2522, PK2578, PK2583, PK2590, PK2644, PK2650, PK2654, PK2672, PK2689, PK2704, PK2705, PK2707, PK2734, PK2746, PK2748, PK2790, PK2803, PK2804, PK2806, PK2807, PK2837, PK7354, PK7381, PK7383, PK7384, PK9715, PK9715D, PK9717, PK9718, PK9720, PK9721, PK9733, PK9744, PK9746, PK9746D, PK9747, PK9748, PK9763, PK9782, PK9783, PK9784, PK9850, PK9851, PK9867, PK9885, PL2099, PL2196, PL2196D, PL2197, PL2197D, PL2198, PL2199, PL2199D, PL2200, PL2200D, PL2407, PL2412, PL2417, PL2417D, PL2418, PL2424, PL2424D, PL2448, PL2449, PL2505, PL2534, PL2538, PL2539, PL2572, PL2583, PL2597, PL2597D, PL2598, PL7126, PL7510, PL7594, PL7595, PL7705, PL7706, PL7799, PL7799D, PL9702, PL9709, PL9710, PL9713, PL9741, PL9741D, PL9745, PL9746, PL9756, PL9820, PL9837, PL9861, PM2071, PM2072, PM2140, PM2142, PM2423, PM2424, PM2465, PM2515, PM2762, PM2763, PM2764, PM7259, PM7448, PM7449, PM7450, PM7533, PM7534, PM7763, PM7763D, PM7764, PM7764D, PM9702, PM9704, PM9715, PM9717, PM9732, PM9734, PM9747, PM9748, PP2048, PP2410, PP2491, PP2536, PP2576, PP2578, PP2715, PP7163, PP7183, PP7184, PP7408S, PP7453, PP7454, PP9707, PP9708, PP9722, PP9723, PP9724, PP9735, PP9750, PP9835, QA2074, QA2075, QA2174, QA2236, QA2311, QA2413, QA2455, QA2486, QA2486D, QA2487, QA2491, QA2576, QA2590, QA2598, QA2609, QA2613, QA2636, QA7249, QA7250, QA7251, QA7956, QA7997, QB2040, QB2041, QB2075D, QB2075S, QB2076S, QB2087, QB2088, QB2121, QB2393, QB7120, QB7120D, QB7121, QB7122, QB7122D, QB7257, QB7703, QB7704, QB7854, QB7973, QB7974, QB9005, QB9006, QB9008, QB9009, QB9033, QB9047, QB9109, QB9134, QB9140, QB9269, QB9272, QB9282, QB9282D, QB9294, QB9340, QB9341, QB9344, QB9345, QB9347, QB9348, QB9373, QB9373D, QB9395, QB9405, QB9406, QB9415, QC2008, QC2015, QC2093, QC2121, QC2267, QC2294S, QC2468, QC2469, QC7139, QC7140, QC7141, QC7142, QC7161, QC7240, QC7241, QC7242, QC7324, QC8025, QC8026, QC9002, QC9004, QC9012, QC9089, QC9095, QC9102, QC9135, QC9252, QC9253, QC9256, QC9257, QC9264, QD2063S, QD2211, QD7624, QD7630, QD7752, QD9002, QD9021, QD9026, QD9029, QD9081, QD9093, QD9093D, QD9095, QD9111, QD9119, QD9120, QD9214, QD9251, QE2132, QE2402, QE2403, QE2404, QE7324, QE7655, QE7828, QE7829, QE9014, QE9016, QE9028, QE9029, QE9043, QE9136, QE9204, QE9233, QE9272, QG2412, QG2424, QG2439, QG2567, QG2568, QG7919, QG8133, QG9067, QG9096, QG9108, QG9130, QG9382, QG9393, QG9425, QG9428, QG9510, QH2040, QH2252, QH7484, QH7899, QH7900, QH7916, QH7918, QH7919, QH7920, QH7921, QH9006, QH9015, QH9017, QH9019, QH9021, QH9022, QH9039, QH9040, QH9041, QH9054, QH9055, QH9056, QH9066, QH9067, QH9073, QH9089, QH9093, QH9105, QH9107, QH9123, QH9141, QH9147, QH9184, QH9217, QH9437, QH9441, QH9446, QJ2017, QJ2263, QJ7337, QJ7504, QJ7614, QJ7938, QJ7976, QJ7977, QJ7978, QJ8014, QJ8015, QJ8033, QJ9004, QJ9019, QJ9033, QJ9058, QJ9059, QJ9075, QJ9081, QJ9082, QJ9135, QJ9136, QJ9161, QJ9162, QJ9195, QJ9208, QJ9252, QJ9275, QJ9357, QJ9366, QK2087, QK2234, QK2235, QK2258, QK2447, QK2456, QK2469, QK2475, QK7504, QK7571, QK7581, QK7592, QK7643, QK7644, QK8012, QK8209, QK8236, QK8257, QK8258, QK9016, QK9066, QK9067, QK9077, QK9088, QK9089, QK9115, QK9119, QK9120, QK9141, QK9152, QK9154, QK9169, QK9213, QK9215, QK9216, QK9248, QK9256, QK9257, QK9258, QK9259, QK9263, QK9280, QK9281, QK9315, QK9371, QK9399, QK9411, QK9427, QL2459, QL2462, QL2489, QL7504, QL7505, QL7703, QL7960, QL7961, QL8056, QL9026, QL9061, QL9062, QL9081, QL9139, QL9157, QL9238, QL9273, QL9306, QL9309, QL9313, QL9324, QL9347, QL9348, QL9356, QL9364, QL9365, QL9373, QL9374, QL9375, QL9384, QL9385, QL9394, QL9397, QL9408S, QL9424, QM2021, QM2056, QM2057, QM2084, QM2085, QM7357, QM7448, QM7794, QM7983, QM9020, QM9073, QM9083, QM9092, QM9161, QM9162, QM9163, QM9177, QM9199, QM9204, QM9205, QM9230, QM9249, QM9251, QM9269, QM9312, QM9317, QM9352, QP2050, QP2056, QP2070, QP2072, QP2083, QP2110, QP2111, QP2126, QP2127, QP2157, QP2167, QP2169, QP2182, QP2185, QP2227, QP2228, QP2406, QP7568, QP7579, QP7775, QP7960, QP8017, QP8018S, QP9364, QP9392, QP9452, RA2026, RA2038, RA2414, RA2560, RA7572, RA8206, RA9010, RA9034, RA9035, RA9039, RA9040, RA9059, RA9063, RA9102, RA9141, RA9163, RA9164, RA9172, RA9223, RA9363, RA9390, RA9393, RA9426, RB2214, RB2215, RB2258, RB7053, RB7489, RB7687, RB7912, RB9015, RB9016, RB9063, RB9083, RB9087, RB9092, RB9094, RB9095, RB9096, RB9128, RB9150, RB9161, RB9175, RB9201, RB9206, RB9240, RB9251, RB9274, RB9283, RB9290, RC2163, RC2419, RC2420, RC7331R, RC7477, RC7498, RC7499, RC7644, RC8146, RC9009, RC9014, RC9015, RC9055, RC9073, RC9098, RC9123, RC9136, RC9137, RC9138, RC9144, RC9158, RC9173, RC9174, RC9189, RC9202, RC9226, RC9227, RC9233, RC9234, RC9246, RC9248, RC9258, RC9295, RC9299, RC9307, RC9324, RC9371, RC9373, RC9384, RC9385, RC9386, RD2090, RD2164, RD2173, RD2268, RD2304, RD2338, RD7914, RD7978, RD9045, RD9046, RD9047, RD9061, RD9117, RD9144, RD9156, RD9166, RD9196, RD9218, RD9230, RD9285, RD9286, RD9440, RD9443, RE2051, RE2084, RE2106, RE2107, RE2144, RE7827, RE8006, RE8108, RE8127, RE8303, RE8352, RE9010, RE9055, (End)

General and Plastic Surgery Devices

2

Yes

There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included. All International customers are the J&J; Medical Products Distribution Ctrs located in Australia, Canada, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, and Thailand.

Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.

D100622   Product Code Lot Number Expiration Date  199102S 237115 8/31/2012 199102S 238568 9/30/2012 199102S 238569 11/30/2012 199102S 237493 6/30/2012 2993 235489 11/30/2012 2993 238599 3/31/2013 2993SAMP 238369 3/31/2013 SAMP199102S 237493 6/30/2012 SAMP199102S 283569 11/30/2012

General and Plastic Surgery Devices

3

Yes

USA (nationwide)

Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip || Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA || Manufactured by Ferrosan Medical Devices || Ferrosan Medical Devices A/S || Sydmarken 5, DK-2860 Soeberg, Denmark || Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.