États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lack of Assurance of Sterility
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Potential for thrombus formation during prolonged use of the introducer.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Joy Plain Chaash Lassi 16 oz., 64 oz.
Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Joy Rose Lassi 16 oz.
Joy Rose Lassi 16 oz.
Product not adequately pasteurized
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
Incorrect product formulation: bag did not contain copper and famotidine per label.
Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108
Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108
Parking lights and daytime running lights that fail to illuminate properly reduce the vehicle's visibility to other drivers, increasing the risk of a crash.
6/11oz No Salt Sunflower Seeds
6/11oz No Salt Sunflower Seeds
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
BMW of North America, LLC - Integrated Brake System Malfunction
BMW of North America, LLC - Integrated Brake System Malfunction
A loss of power brake assist can extend the distance required to stop the vehicle. Additionally, malfunctioning ABS and/or DSC systems can cause a loss of vehicle control. Either of these scenarios can increase the risk of a crash.
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Joy Saffron Cardamon Lassi 16 oz.
Joy Saffron Cardamon Lassi 16 oz.
Product not adequately pasteurized
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Potential presence of Salmonella.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Spring & Mulberry Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light brown box, UPC 850055470224, 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 Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light brown box, UPC 850055470224, 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
25# Sunflower Seeds C/S
25# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
Potential presence of Salmonella.
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Joy Peach Lassi 16 oz.
Joy Peach Lassi 16 oz.
Product not adequately pasteurized