Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump…
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly,…
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- Maquet Medical Systems
- Product
- Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood…
- Classification
- Class II
- Units
- US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medical Systems recalls
- 2023-12-13
USMaquet Medical Systems USA recalls CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide…
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and…
FDA · DeviceMaquet Medical Systems USAUS Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC,…Official notice →- 2023-11-15
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Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual…
- 2023-06-07
- US
Maquet Medical Systems USA recalls QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,…
- US
Maquet Medical Systems USA recalls QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may…
- 2023-03-08
- US
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.…
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2022-09-28
- US
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries Canada and Australia.Official notice →
Other drugs & medical recalls in the United States
- 2022-04-20
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Teva Pharmaceuticals USA Inc recalls IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals,…
Presence of Particulate Matter: Product was found to contain silica and iron oxide
- 2022-04-14
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Rae Wellness Recalls Prenatal and Immunity Dietary Supplements Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products are dietary supplements containing iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a…
- 2022-04-13
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MEDLINE INDUSTRIES, LP - Northfield recalls Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV…
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide Distribution was made to KY, OK, and TX. There was no…Official notice → - US
DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
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