États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
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.
Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg. (packed under 5 labels: Off Grade NFDM Variable; Extra Grade NFDM Standard rBST Free; Grade A NFDM LH Basic; Grade A NFDM LH Standard rBST Free; Grade A NFDM LH Tier 1 rBST Free)
Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg. (packed under 5 labels: Off Grade NFDM Variable; Extra Grade NFDM Standard rBST Free; Grade A NFDM LH Basic; Grade A NFDM LH Standard rBST Free; Grade A NFDM LH Tier 1 rBST Free)
Potential contamination with Salmonella.
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
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.
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Resorbable bone void filler falls outside standard specifications.
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
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.
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Chemical contamination; presence of lead and lithium above specification
Loard's Chocolate Marble Ice Cream - 32 oz
Loard's Chocolate Marble Ice Cream - 32 oz
Undeclared Milk.
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184
Multi-state outbreak of E. coli O157:H7.
Garland Fresh Peeled Garlic 6 oz. bag
Garland Fresh Peeled Garlic 6 oz. bag
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
MILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349
MILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Loard's Black Walnut Ice Cream - 32 oz; 56 oz
Loard's Black Walnut Ice Cream - 32 oz; 56 oz
Undeclared Milk, Walnuts.
Loard's Ube Ice Cream - 32 oz
Loard's Ube Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
Loard's Green Tea Ice Cream - 32 oz
Loard's Green Tea Ice Cream - 32 oz
Undeclared Milk, Yellow #5.
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
Multi-state outbreak of E. coli O157:H7.
Loard's Peanut Butter Fudge Ice Cream - 32 oz
Loard's Peanut Butter Fudge Ice Cream - 32 oz
Undeclared Milk, Peanuts.
Loard's Pistachio Ice Cream - 32 oz
Loard's Pistachio Ice Cream - 32 oz
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
Cinnamon Creamed Honey 671333101360 * 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: 671333101360
Cinnamon Creamed Honey 671333101360 * 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: 671333101360
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Loard's Burgundy Cherry Ice Cream - 32 oz
Loard's Burgundy Cherry Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1, Blue #2.
XZL, 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