États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DrugsCarton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.
Subpotent Drug
FDA DevicesAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Potential for thrombus formation during prolonged use of the introducer.
FDA Food6/11oz Sunflower Seeds Salted
6/11oz Sunflower Seeds Salted
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
FDA DevicesSurgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DrugsPerampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
FDA DevicesAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Potential for thrombus formation during prolonged use of the introducer.
FDA DevicesOff-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA FoodSpring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a yellow box, UPC 850055470040, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Spring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a yellow box, UPC 850055470040, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Potential Salmonella contamination.
FDA DevicesBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
FDA DevicesSurgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA FoodJoy Masala Chaash Lassi 16 oz., 64 oz.
Joy Masala Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA DevicesOctopus Evolution AS Tissue Stabilizer, Model TS2500
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA DevicesSurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DrugsSensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
FDA Food1.5oz, 8.0oz , Zapp's Big Cheezy Potato Chips, Plastic Bag.
1.5oz, 8.0oz , Zapp's Big Cheezy Potato Chips, Plastic Bag.
Potential presence of Salmonella.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesBrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
FDA Foodboichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
Undeclared allergen, sesame.
FDA DevicesSurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesTMJ Bilateral Implants, REF: CHG020
TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
FDA FoodJoy Strawberry Lassi 16 oz.
Joy Strawberry Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.