États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DrugsGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
FDA FoodNEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIONAL SUPPLEMENT TO SUPPORT DRAIN AND GUT HEALTH NET WT. 5.9 OZ; UPC: 310M5951601
NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIONAL SUPPLEMENT TO SUPPORT DRAIN AND GUT HEALTH NET WT. 5.9 OZ; UPC: 310M5951601
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
FDA FoodFlan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959
Flan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodCheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116
Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DrugsDOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
Presence of Particulate matter: Particulate matter identified as glass.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
FDA FoodCheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DrugsZep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Microbial contamination of sterile products
FDA DevicesCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
FDA DevicesAllia Moveo angiographic X-ray system
Allia Moveo angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA DevicesBicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
FDA DevicesHalyard, Pain Pack. Kit Code: AMPK48-01.
Halyard, Pain Pack. Kit Code: AMPK48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
FDA DevicesProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesTDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
FDA DevicesBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Due to incorrect incubation process being performed on product.
FDA DevicesAllia IGS Pulse angiographic X-ray system
Allia IGS Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA DevicesMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA DevicesBrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
FDA DevicesEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
FDA DevicesHintermann Series Talar Implant, Left, Size 2 REF 302112
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
FDA FoodCheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852829
Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852829
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesMOSAIQ Oncology Information System
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA DevicesMedartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
The cannulation of the CCS screw is not centered.