Carefusion 2200 Inc

product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Anesthesiology Devices

2

No

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico || Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Anesthesiology Devices

2

No

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico || Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Anesthesiology Devices

2

No

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico || Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

tray catalog number 4469A. tray lot numbers 0000312078, 0000312079, 0000313237, 0000315474, 0000317224, 0000317225, 0000317226, 0000319388, 0000319398, 0000319399, 0000319400, 0000321995, 0000326091, 0000330888, 0000331259, 0000331933, 0000333748, 0000333749, 0000333750, 0000336430, 0000336454, 0000340623, 0000342778, 0000342779, 0000342780, 0000344796, 0000347085, 0000348120, 0000351690, 0000354083, 0000356290, 0000361072, Y10S1161, Y10S1568, Y10S2006, Y10S2007, Y10S2364, Y10S2993, Y11A1149, Y11A2470, Y11A3023, Y11B0434, Y11B0955, Y11B1613, Y11B2924, Y11C0276, Y11C1279, Y11C1855, Y11C3087, Y11D0543, Y11D0779

Obstetrical and Gynecological Devices

1

No

Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.

Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4469A || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.

tray catalog number 4468. tray lot numbers 0000310407, 0000310409, 0000310411, 0000310413, 0000312077, 0000312080, 0000312081, 0000313225, 0000313227, 0000313229, 0000313233, 0000313523, 0000314761, 0000314762, 0000315476, 0000315477, 0000315478, 0000315480, 0000317227, 0000317229, 0000317230, 0000317231, 0000318349, 0000318350, 0000318351, 0000318352, 0000319401, 0000319402, 0000319403, 0000319404, 0000319405, 0000321997, 0000321998, 0000321999, 0000322000, 0000322001, 0000323739, 0000323740, 0000323741, 0000326095, 0000326097, 0000326099, 0000326100, 0000326101, 0000326103, 0000326104, 0000328472, 0000328473, 0000328474, 0000328475, 0000328497, 0000328502, 0000328504, 0000330880, 0000330881, 0000330884, 0000330885, 0000330886, 0000333712, 0000333754, 0000333755, 0000333756, 0000333757, 0000333758, 0000333759, 0000333761, 0000333762, 0000336431, 0000336433, 0000336434, 0000336435, 0000336437, 0000336439, 0000336442, 0000336448, 0000336449, 0000336450, 0000336451, 0000336452, 0000336453, 0000342781, 0000342782, 0000342783, 0000342785, 0000342786, 0000342787, 0000342788, 0000342789, 0000342790, 0000344054, 0000344798, 0000344800, 0000344810, 0000344811, 0000344812, 0000347086, 0000347087, 0000347088, 0000347090, 0000347091, 0000347093, 0000347094, 0000347095, 0000347096, 0000349465, 0000349466, 0000349467, 0000349473, 0000349812, 0000351290, 0000351684, 0000351687, 0000354085, 0000354087, 0000354089, 0000354091, 0000354096, 0000354100, 0000356292, 0000356294, 0000356296, 0000356299, 0000356300, 0000361254, 0000361255, 0000361284, 0000615475, Y1051567, Y10S2362, Y10S2363, Y10S2370, Y10S2371, Y10S2372, Y10S2402, Y10S2436, Y10S2988, Y10S2989, Y10S2990, Y10S3008, Y10S3011, Y1053012, Y10S3118, Y10S3119, Y11A0340, Y11A0341, Y11A0347, Y11A0349, Y11A1125, Y11A1139, Y11A1147, Y11A1148, Y11A1155, Y11A1270, Y11A1980, Y11A1981, Y11A1982, Y11A2013, Y11A2014, Y11A2637, Y11A2638, Y11A2639, Y11A2729, Y11A2733, Y11A2734, Y11A3238, Y11A3239, Y11A3240, Y11B0276, Y11B0279, Y11B0290, Y11B0411, Y11B0603, Y11B0949, Y11B0959, Y11B0960, Y11B0961, Y11B1240, Y11B1241, Y11B1427, Y11B1651, Y11B2564, Y11B2566, Y11B2925, Y11B2927, Y11B2928, Y11B2932, Y11C0274, Y11C0275, Y11C0283, Y11C0284, Y11C0318, Y11C0319, Y11C0320, Y11C1275, Y11C1276, Y11C1277, Y11C1278, Y11C1280, Y11C1976, Y11C1977, Y11C2146, Y11C2147, Y11C2865, Y11C3085, Y11C3086, Y11C3103, Y11C3104, Y11C3105, Y11C3141, Y11C3142, Y11C3744, Y11C3745, Y11C3746, Y11C3752, Y11D0541, Y11D0542, Y11D0777, Y11D0778, Y11D0783, Y11D0784, Y11D0785, Y11D0786, Y11D0787

General and Plastic Surgery Devices

1

No

Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.

Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4468 || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.