Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Custom Procedure Kit, REF: K12T-11077
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-04-02
USMerit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
FDA · DeviceMerit Medical Systems, Inc.International distribution to the country of Japan.Official notice →- 2024-10-23
- US
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Merit 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 → - 2024-08-21
- US
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 → - 2024-07-03
- US
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…
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-05-29
- US
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 →
Other drugs & medical recalls in the United States
- 2024-10-02
- US
Bard Peripheral Vascular Inc recalls BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System…
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the Puerto Rico and the countries…Official notice → - US
Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Argon Medical Devices, Inc recalls BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03,…
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to…
FDA · DeviceArgon Medical Devices, IncWorldwide - US Nationwide distribution including in the states of AZ, FL, OH,…Official notice → - US
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - US
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
- US
FUJIFILM Healthcare Americas Corporation recalls The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID)…
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the…