The Recall Desk

Archive

January 2023 recalls

460 recalls were announced in January 2023.

What the numbers show

Critical
4
Severe
46
High
307
Moderate
103

Of the 460 recalls this month scored against our rubric, 1% are Critical, 10% are Severe.

301–400 of 460

  • HighNHTSA·23V005000·2023-01-13

    ABS Remorques semi-trailers recalled for coupling plate deterioration

    ABS Remorques is recalling 2014-2023 RC, WC, LRC, and LWC semi-trailers due to coupling plate deterioration that may cause king pin failure and trailer detachment. Detached trailers cannot be controlled and may crash or obstruct traffic.

    Product
    ABS REMORQUES — ABS REMORQUES LWC, LRC, WC, RC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E004000·2023-01-13

    Comoto Recalls Bilt Vertex Helmets for Safety Standard Non-Compliance

    Comoto Holdings is recalling specific Bilt Vertex motorcycle helmets because they may lack proper retention and penetration protection, increasing crash injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23091·2023-01-12

    BISSELL Cordless Wet Dry Vacuums Recalled for Fire Hazard

    BISSELL Cordless Multi-Surface Wet Dry Vacuums (models 2551, 2551W, and 25519) are recalled because the battery pack circuit board can overheat and catch fire. The company has received 66 reports of smoking and burning odor, including five fires and one burn injury.

    Product
    BISSELL® Cordless Multi-Surface Wet Dry Vacuums Models 2551, 2551W and 25519
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23722·2023-01-12

    MI Windows and Doors 1620 Vinyl Single-Hung Impact Windows Recall

    MI Windows and Doors is recalling about 25,000 model 1620 vinyl single-hung impact windows with window opening control devices due to a defective tilt latch that can cause the control devices to malfunction, posing fall and serious injury hazards.

    Product
    1620 vinyl single-hung impact windows with window opening control devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V003000·2023-01-12

    Altec Recalls 2022 Digger Derrick Vehicles Due to Incorrect Bolt

    Altec is recalling 2022 Digger Derrick vehicles because an incorrect bolt may have been used on the derrick rotation bearing, increasing the risk of injury.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23090·2023-01-12

    2019-2021 Honda Talon 1000 ROVs Recalled for Engine Failure and Crash Risk

    American Honda is expanding its recall of 2019-2021 Honda Talon 1000 recreational off-highway vehicles because a loose intake funnel band screw can enter the engine, cause sudden failure, and result in loss of control and crashes.

    Product
    2019-2021 Honda Talon 1000 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23721·2023-01-12

    LG 86-inch Smart Televisions Recalled for Tip-Over and Entrapment Hazards

    LG is recalling about 52,000 of its 86-inch smart televisions with stands because the stand can become unstable, creating tip-over and entrapment hazards that can result in injuries or death. Consumers should immediately detach the stands and place the TVs in a safe location away from children.

    Product
    LG 86-inch smart televisions and stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0224-2023·2023-01-11

    Culvers Tartar Sauce 2 oz Cups Recalled for Undeclared Allergens

    Culvers tartar sauce is being recalled because it contains undeclared fish, soy, and milk allergens. Food service locations should remove the product immediately.

    Product
    Culvers Tartar Sauce 2 oz. plastic cups
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0214-2023·2023-01-11

    Cranberry Sweets Meltaway Recalled for Undeclared Peanut Allergen

    Cranberry Sweets & More Inc is recalling Peanut Butter Meltaway chocolates mislabeled as Mint Meltaways. The product contains undeclared peanut, a major food allergen, posing risk to allergic consumers.

    Product
    Recalled Meltaways product is packaged in clear cellophane bags, net wt. 4oz and 8 oz. and has no UPC. The front label is read Mint Meltaways, Cranberry Sweets and more, Coos Bay, OR 97402. The back label is read Heirloom Mint Meltaways, Ingredients: Milk Chocolate (***soy lecit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0220-2023·2023-01-11

    Three Gold Coins Dried Mushrooms Recalled for Salmonella Contamination

    Tai Phat Wholesalers LLC is recalling Three Gold Coins Dried Mushrooms due to Salmonella contamination. The product was distributed to multiple states including Florida, New York, and Pennsylvania.

    Product
    Three Gold Coins, Dried Mushrooms (01052) Nam Meo Nguyen Tai S- 50x2.5 oz
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0216-2023·2023-01-11

    Power Life Protein Powder Recalled Due to Undeclared Milk

    Power Life High Impact Plant Protein in chocolate flavor is recalled because the product label does not declare milk as an ingredient, creating a serious allergic reaction risk for milk-allergic consumers.

    Product
    Power Life by Tony Horton High Impact Plant Protein Chocolate Flavor NET WT 446 G (15.7 OZ) Ingredients: Vegan Protein Mix (pumpkin, sunflower, flax)(as ProteoSMART), Mung Bean Protein, myHMB (Calcium Beta-hydroxy-Beta-Methlbutyrate), Alkalized Cocoa Powder, Pea Protein Powder,
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0219-2023·2023-01-11

    Three Gold Coins Dried Mushrooms Recalled Due to Salmonella Contamination

    Three Gold Coins Dried Mushrooms Sliced have been recalled due to Salmonella contamination. Affected product was distributed across 15 U.S. states.

    Product
    Three Gold Coins, Dried Mushrooms Sliced (01276) Nam Meo Soi L- 24x10.5 oz.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0221-2023·2023-01-11

    Dried mushrooms recalled due to Salmonella contamination

    Three Gold Coins dried mushrooms have been recalled due to Salmonella contamination. Consumers should not consume the product.

    Product
    Three Gold Coins, Dried Mushrooms (01277) Nam Meo Nguyen Tai L- 24x10.5 oz
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0218-2023·2023-01-11

    Three Gold Coins Dried Mushrooms Recalled for Salmonella Contamination

    Three Gold Coins brand dried mushrooms have been recalled due to Salmonella contamination. Approximately 341.2 cases were distributed across 15 U.S. states.

    Product
    Three Gold Coins, Dried Mushrooms Sliced (01051) Nam Meo Soi S- 50x2.5 oz
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0217-2023·2023-01-11

    Members Mark Holiday Macarons recalled for potential plastic particle contamination

    Sam's Club is recalling Members Mark Holiday Macarons due to potential plastic particle contamination. Approximately 148,800 units distributed in Illinois are affected.

    Product
    Members Mark Holiday Macarons 540g units in plastic trays, 10 units per case Keep frozen, refrigerate after opening UPC: 193968321123 Distributed by: Sam's West, Inc. Bentonville, AR 72716 Product of Canada
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·PHA-01112023-01·2023-01-11

    Frozen Swai Fried Fish Cutlets Produced Without Federal Inspection

    USDA FSIS issued a public health alert for frozen swai fried fish cutlets produced without federal inspection. Consumers are advised to discard the products.

    Product
    FSIS Issues Public Health Alert for Fully Cooked, Frozen Swai Fried Fish Cutlet Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2023·2023-01-11

    Shower/Commode Chair Recalled Due to Frame Folding Defect

    Altimate Medical is recalling the ActiveAid 922 Shower/Commode Chair because a manufacturing defect prevents the frame from folding properly and being secured by the frame strap in the folded position.

    Product
    ActiveAid 922, Shower/Commode Chair
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2023·2023-01-11

    API 20 C AUX Diagnostic Strips Recalled Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.

    Product
    API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2023·2023-01-11

    VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions

    Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.

    Product
    VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2023·2023-01-11

    FDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes

    Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.

    Product
    Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0222-2023·2023-01-11

    Super Seed Classic Crackers Recalled for Possible Rubber Contamination

    Mary's Gone Crackers is recalling Super Seed Classic Crackers due to possible rubber piece contamination in affected lots. Consumers should stop consuming the product.

    Product
    Super Seed Classic Crackers (6 pk.) 5.5 oz. UPC: 8 97580 00016 8
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0775-2023·2023-01-11

    Programmable Diagnostic Computer Software Update Addresses Crash Errors

    Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.

    Product
    Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2023·2023-01-11

    Steris Biological Indicator Lot May Fail to Detect Inadequate Sterilization

    Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.

    Product
    VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2023·2023-01-11

    ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.

    Product
    ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2023·2023-01-11

    VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2023·2023-01-11

    VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure

    Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.

    Product
    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2023·2023-01-11

    ETEST Meropenem antibiotic susceptibility test recalled due to storage excursion

    Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.

    Product
    ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2023·2023-01-11

    Biomerieux PPM Culture Plates Recalled for Storage Stability Issues

    Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.

    Product
    PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2023·2023-01-11

    VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.

    Product
    VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0095-2023·2023-01-11

    Injectable Acyclovir Sodium Recalled for Particulate Matter Contamination

    Eugia US LLC is recalling Acyclovir Sodium Injection (45,250 vials) distributed nationwide due to the presence of dark particles found inside vials.

    Product
    ACYCLOVIR SODIUM — ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2023·2023-01-11

    FDA Recalls Antibiotic Susceptibility Test Strips Due to Storage Condition Excursion

    Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2023·2023-01-11

    Disposable Trocars Lack Printed Expiration Dates on Packaging

    ENDO Pharmaceuticals is recalling 2,603 disposable trocars because packaging does not include printed expiration dates, creating risk of use of expired sterile devices.

    Product
    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2023·2023-01-11

    FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.

    Product
    VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0223-2023·2023-01-11

    Super Seed Everything Crackers recalled for possible rubber pieces

    Mary's Gone Crackers is recalling Super Seed Everything Crackers due to potential rubber pieces in the product. Consumers should not consume the affected product with lot number 4CKR5410.

    Product
    Super Seed Everything Crackers 5.5 oz. UPC: 8 53665 00509 1
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0834-2023·2023-01-11

    VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure

    Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.

    Product
    VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2023·2023-01-11

    VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure

    Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2023·2023-01-11

    ETEST Minocycline Susceptibility Test Affected by Storage Temperature Exceedance

    Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.

    Product
    ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2023·2023-01-11

    VIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure

    Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.

    Product
    VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2023·2023-01-11

    Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion

    Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2023·2023-01-11

    FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.

    Product
    PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2023·2023-01-11

    ETEST Clinical Eravacycline ERV test kit recalled for temperature storage excursion

    Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.

    Product
    ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2023·2023-01-11

    Biomerieux Recalls VIDAS LH 60 Clinical Tests for Temperature-Induced Performance Issues

    Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.

    Product
    VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2023·2023-01-11

    Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions

    Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.

    Product
    VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2023·2023-01-11

    Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.

    Product
    API 20 E 25 STRIPS, CATALOG 20100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2023·2023-01-11

    Laboratory quality control material with degraded potency affecting diagnostic verification

    Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.

    Product
    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2023·2023-01-11

    FDA Recalls ETEST Ertapenem Antibiotic Susceptibility Test Due to Storage Damage

    Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.

    Product
    ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2023·2023-01-11

    ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion

    Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2023·2023-01-11

    Steris Biological Indicators Recalled for Inconsistent Spore Growth

    Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because some units in lot 230613 fail to consistently promote spore growth, potentially masking failed sterilization cycles.

    Product
    VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2023·2023-01-11

    FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion

    Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.

    Product
    ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2023·2023-01-11

    Measles Antibody Test Kits Recalled Due to Temperature Excursion

    Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.

    Product
    VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2023·2023-01-11

    Listeria Detection Test Strips Recalled for Unreliable Performance

    Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.

    Product
    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2023·2023-01-11

    VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion

    Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2023·2023-01-11

    VITEK 2 Antibiotic Susceptibility Test Kits Recalled Due to Storage Condition Failures

    Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.

    Product
    VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2023·2023-01-11

    Clinical reagent recalled due to temperature and time excursion

    Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2023·2023-01-11

    VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure

    Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.

    Product
    VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2023·2023-01-11

    ETEST Amikacin Test Strips Recalled for Storage Condition Excursion

    Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2023·2023-01-11

    VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance

    Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.

    Product
    VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2023·2023-01-11

    Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation

    Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2023·2023-01-11

    TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion

    Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.

    Product
    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0838-2023·2023-01-11

    Medical device test kit recalled due to storage temperature and time excursion

    Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations

    Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.

    Product
    VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2023·2023-01-11

    Steris VERIFY Steam Test Pack biological indicators show inconsistent performance

    Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.

    Product
    VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2023·2023-01-11

    Culture Medium Recall Due to Temperature Excursion Affecting Product Performance

    Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.

    Product
    PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2023·2023-01-11

    Gene-Up Lysis Kit Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.

    Product
    GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2023·2023-01-11

    Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise

    Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.

    Product
    Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2023·2023-01-11

    ETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.

    Product
    ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2023·2023-01-11

    VITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure

    Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.

    Product
    VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2023·2023-01-11

    Medical Laboratory Diagnostic Media Recalled Due to Storage Condition Violations

    Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.

    Product
    PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2023·2023-01-11

    ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage

    Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.

    Product
    ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2023·2023-01-11

    Detect COVID-19 Test may produce false negative results in affected lots

    Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.

    Product
    Detect Covid-19 Test Product/Model Number: 21205
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2023·2023-01-11

    Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload

    The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.

    Product
    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0860-2023·2023-01-11

    ETEST Vancomycin Susceptibility Test Recalled Due to Storage Damage

    Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.

    Product
    ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2023·2023-01-11

    DeRoyal Tonsillectomy Tray recalled for potential suction port occlusion

    DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.

    Product
    DeRoyal Tonsillectomy Tray, REF 89-10698.01
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0808-2023·2023-01-11

    API VP1 VP2 Medical Reagents Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.

    Product
    API VP1 VP2 REAGENTS, CATALOG 70422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2023·2023-01-11

    API JAMES 2AMP Clinical Diagnostic Device Recall Due to Storage Condition Violations

    Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.

    Product
    API JAMES 2AMP, CATALOG 70542
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2023·2023-01-11

    Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation

    Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.

    Product
    ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2023·2023-01-11

    FDA Recalls PPM Lombard TSA Culture Medium Due to Storage Temperature Exceedance

    Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.

    Product
    PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2023·2023-01-11

    ETEST Clinical Erythromycin test plates recalled for storage temperature deviation

    Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.

    Product
    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2023·2023-01-11

    FDA Recalls ETEST Fluconazole Susceptibility Test due to Storage Excursion

    Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.

    Product
    ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2023·2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2023·2023-01-11

    Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

    Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.

    Product
    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions

    Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.

    Product
    VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2023·2023-01-11

    Biomerieux VIDAS Progesterone Tests Recalled for Storage Condition Failure

    Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.

    Product
    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2023·2023-01-11

    PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect

    Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2023·2023-01-11

    Epi-Caine Intraocular Injection Recalled Due to Raw Material Discoloration

    Pine Pharmaceuticals is recalling Epi-Caine intraocular injection (11,453 vials nationwide) due to discoloration in raw material used for compounding, a manufacturing quality control failure.

    Product
    Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2023·2023-01-11

    Medical Diagnostic Device Recalled Due to Temperature and Time Excursions

    Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.

    Product
    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2023·2023-01-11

    VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

    Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

    Product
    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2023·2023-01-11

    ETEST Antibiotic Susceptibility Test Kit Recalled for Storage Degradation

    Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.

    Product
    ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0854-2023·2023-01-11

    Biomerieux VITEK 2 AST-GN99 Diagnostic Test Kit Recalled for Storage Stability

    Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise test performance.

    Product
    VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
    Category
    Medical Device
    Distribution
    Distributed nationwide

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