Maquet Cardiovascular, LLC recalls HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of…
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double…
Read the official notice →- Date
- 2022-03-16
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of…
- Classification
- Class II
- Units
- US Nationwide distribution in the state of MO.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Maquet Cardiovascular recalls
- 2023-04-12
USMaquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Some batches of product were not sterilized to their minimum sterilization specification.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Brazil, China.Official notice →- 2023-03-22
- US
Maquet Cardiovascular, LLC recalls Fusion Bioline Vascular Graft, Part number M00201503046B0
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY,…Official notice → - 2023-01-25
- US
Maquet Cardiovascular, LLC recalls Vasoshield Syringe Packs, Model VH-5001
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
- 2022-06-29
- US
Maquet Cardiovascular, LLC recalls INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and…
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the state of SC.Official notice → - 2022-04-13
- US
Maquet Cardiovascular, LLC recalls Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX,…Official notice → - 2021-12-29
- US
Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of IL and NC.Official notice →
Other drugs & medical recalls in the United States
- 2022-03-16
- US
Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST;…
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
FDA · DeviceBrainlab AGDistribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY,…Official notice → - US
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2…
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new…
- US
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Kits were labeled with incorrect expiration dates.
FDA · DeviceCELLTRION USA INCThe products were distributed to the following US states: CA, CT, FL, HI, MA,…Official notice → - US
Stryker Corporation recalls 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and…
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical…
FDA · DeviceStryker CorporationWorldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL,…Official notice → - US
B. Braun Medical, Inc. recalls Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of…
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC,…Official notice → - US
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is…
FDA · DeviceHeartware, Inc.Distribution throughout the United States. OUS distribution in Argentina,…Official notice →