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…
Read the official notice →- Date
- 2021-12-29
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IL and NC.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2022-03-16
- US
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…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the state of MO.Official notice →
Other drugs & medical recalls in the United States
- 2021-12-29
- US
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
FDA · DeviceROi CPS LLCDistribution was made to Missouri. There was no foreign/military/government…Official notice → - US
Beaver Visitec International, Inc. recalls Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part…
Kit packaging may have small holes compromising product sterility
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IL, OH, MS, and PA.Official notice → - US
Hill-Rom Inc. recalls These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0…
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
- US
Wright Medical Technology, Inc. recalls Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc…
Incorrect product is contained in the packaging.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, IA,…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice →