États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesHalyard CATH LAB kit. Model Number: SACL75AM.
Halyard CATH LAB kit. Model Number: SACL75AM.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DrugsLactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Presence of Particulate Matter.
FDA FoodLoard's Mocha Almond Fudge Ice Cream - 32 oz
Loard's Mocha Almond Fudge Ice Cream - 32 oz
Undeclared Milk, Almonds, Soy.
FDA DevicesDEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA FoodDark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101407
Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101407
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA FoodBurgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Undeclared Red #40, Blue #1, Blue #2
FDA FoodWoodstock Organic Shelled Edamame 10 oz. and 48 oz.
Woodstock Organic Shelled Edamame 10 oz. and 48 oz.
Foreign object: metal pieces
FDA DevicesOne Step 10A in vitro diagnostic test
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
FDA FoodMILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA
MILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
FDA FoodLoard's Peanut Butter Fudge Ice Cream - 32 oz
Loard's Peanut Butter Fudge Ice Cream - 32 oz
Undeclared Milk, Peanuts.
FDA FoodLoard's Rainbow Sherbert - 32 oz
Loard's Rainbow Sherbert - 32 oz
Undeclared Milk, Soy, Yellow #5, Red #40, Green #3.
FDA DevicesDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesMedline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesMedline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodFain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA DevicesMedline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodLoard's Peppermint Ice Cream - 32 oz; 56 oz
Loard's Peppermint Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy, Red #40.
NHTSAHale Products Inc - Touch Screen Display May Fail
Hale Products Inc - Touch Screen Display May Fail
A loss of exterior lights can reduce the visibility of the vehicle to other drivers, increasing the risk of a crash. Inoperative equipment can delay emergency response, increasing the risk of injury.
FDA FoodHatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339
Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
NHTSALucid USA, Inc. - Inverter May Fail and Cause a Loss of Drive Power
Lucid USA, Inc. - Inverter May Fail and Cause a Loss of Drive Power
A loss of drive power increases the risk of a crash.
FDA DevicesBrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA FoodXZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
Product Contains undeclared FD&C Yellow #5 & #6 and Red #40
FDA DevicesMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesMedline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.