Devices

Device Recall CareFusion

Model / Serial
1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111; 2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111; 5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212; 6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110; 7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410; 8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312; 9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312; 10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211; 11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410; 12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213; 13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310; 14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410; 15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210; 16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110; 17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312; 18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111; 19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310; 20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number: 110410, 120212; 21) Instrumed Item No.: 250-08860; CareFusion Catalog Code: LA8507; Lot Number: 011111, 020111, 030210, 041411, 060112, 060313, 070312, 070712, 100413, 100512, 110112, 110313, 110413; 22) Instrumed Item No.: 250-08880; CareFusion Catalog Code: LA8507-45; Lot Number: 061011, 070313, 070513; 23) Instrumed Item No.: 250-08890; CareFusion Catalog Code: LA8506; Lot Number: 020211, 020410; 24) Instrumed Item No.: 250-08900; CareFusion Catalog Code: LA8506-45; Lot Number: 050407; 25) Instrumed Item No.: 250-08930; CareFusion Catalog Code: LA8505; Lot Number: 010314, 010513, 010611, 030113, 032211, 040112, 090313, 100111, 120710; 26) Instrumed Item No.: 250-08960; CareFusion Catalog Code: LA8505-45; Lot Number: 30313, 090113, 110110, 120211; 27) Instrumed Item No.: 250-08970; CareFusion Catalog Code: LA8504; Lot Number: 050110, 080510; 28) Instrumed Item No.: 250-08980; CareFusion Catalog Code: LA8504-45; Lot Number: 050311; 29) Instrumed Item No.: 250-08990; CareFusion Catalog Code: LA8503; Lot Number: 020414, 042310, 110411; 30) Instrumed Item No.: 250-09000; CareFusion Catalog Code: LA8503-45; Lot Number: 020512; 31) Instrumed Item No.: 250-09010; CareFusion Catalog Code: LA8509; Lot Number: 020413, 021511, 030211, 030212, 030G12, 03101816-; 32) Instrumed Item No.: 250-09030; CareFusion Catalog Code: LA8509-45; Lot Number: 070212; 33) Instrumed Item No.: 250-09040; CareFusion Catalog Code: LA8510; Lot Number: 040411; 34) Instrumed Item No.: 250-09070; CareFusion Catalog Code: LA8508-45; Lot Number: 050410; 35) Instrumed Item No.: 250-09100; CareFusion Catalog Code: VM46-9183; Lot Number: 060411; 36) Instrumed Item No.: 250-09120; CareFusion Catalog Code: VM46-9185; Lot Number: 090308
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Product Description
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. || The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
Manufacturer
Instrumed International, Inc.
1 Event
- Recall of Device Recall CareFusion

Manufacturer

Instrumed International, Inc.

Manufacturer Address
Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
Manufacturer Parent Company (2017)
Avalign Technologies Inc.
Source
USFDA

10 devices with a similar name

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Device Recall CareFusion Vital Signs LightWand Stylet

Model / Serial
Catalog Number 3910
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
CareFusion Vital Signs LightWand Stylet. || A device inserted into an endotracheal tube to aid in the intubation procedure.
Manufacturer
Vital Signs Colorado Inc.

Device Recall CareFusion Vital Signs Introduction Pack

Model / Serial
Catalog Number 3960
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Manufacturer
Vital Signs Colorado Inc.

Device Recall CareFusion

Model / Serial
9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13621847 13622337 13624519 13628251 13628876 13628877 13628918 13629153 13658756 13732201 13744088 13781347 13782359 13796475 13809762 13813539 13818275 13853185 13853375 13858182 13858798 13858976 13862567 13867168 13895850 13895989 13896107 13896108 13896110 13896347 13896456 13896669 13896747 13896748 13910604 13922145 13951711 13994625 13995332 14000190 14006401 14035430 14036040 14084571 14084629 14126982 14126990 14151686 14152555 14172846 14190913 14228679 14235981 14253982 14258801 14259542 14280651
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution.
Product Description
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
Manufacturer
CareFusion 303, Inc.

Device Recall CareFusion, SnowdenPencer, DiamondFlex

Model / Serial
Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Product Description
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.
Manufacturer
Carefusion 2200 Inc

Device Recall CareFusion Wet PVPI Small Procedure Preoperative Skin Prep Tray

Model / Serial
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
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Carefusion 2200 Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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