États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Bicarby" 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.
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852775
Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852775
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454
Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320
Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
NexxZr T Multi A3.5 W98-16mm, REF: 745451
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
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.
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.
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 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, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 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.
Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 882479852232
Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 882479852232
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Allia 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.
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
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).
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
Undeclared FD&C Red 40
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
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).
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
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.
DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 721557533567
DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 721557533567
Potential contamination with lead.
Merlin" 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.
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.