Device Recall CareFusion

Catalog Number 3910

Anesthesiology Devices

1

No

Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.

CareFusion Vital Signs LightWand Stylet. || A device inserted into an endotracheal tube to aid in the intubation procedure.

Catalog Number 3960

Anesthesiology Devices

1

No

Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.

Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.

Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.

DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. || Designed to retract or elevate organs and tissue to provide better visualization access.

tray catalog number 4420. tray lot numbers 0000319389, 0000321446, 0000323733, 0000326090, 0000328468, 0000330882, 0000333747, 0000336418, 0000336443, 0000340606, 0000344792, 0000349464, 0000354078, 0000354079, 0000358785, 0000367470, Y11Cl711, Y11C2202, Y11C3733, Y11C3751, Y11D0544

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 Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL 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 4420 || 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.