Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS…
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel…
Read the official notice →- Date
- 2024-07-03
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Merit Medical Systems recalls
- 2024-10-23
USMerit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe…
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →- 2024-10-02
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Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - 2024-08-21
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Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2024-05-29
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Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice → - 2024-01-10
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Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B,…
The sterility of microcatheter and infusion system devices cannot be guaranteed.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT,…Official notice → - 2023-06-21
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Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-03
- US
ASPEN SURGICAL recalls Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
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Centers For Disease Control and Prevention recalls CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
The H5b component may fail to amplify, resulting in an inconclusive result.
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Stryker GmbH recalls Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
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NovaSignal Corp. recalls NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
FDA · DeviceNovaSignal Corp.Worldwide - US Nationwide distribution in the states of MA, TX, NY, MN, AZ,…Official notice → - US
Thoratec Switzerland GMBH recalls 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411,…
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down…
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Siemens Healthcare Diagnostics Inc recalls Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas…
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and…Official notice →