Maquet 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…
Read the official notice →- Date
- 2023-12-13
- Country
- United States
- Brand
- Maquet Medical Systems
- Product
- CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal…
- Classification
- Class I
- Units
- US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-12-27
USMaquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be…
FDA · DeviceMaquet Medical Systems USADomestic distribution Nationwide. Foreign distribution to Argentina,…Official notice →- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the…
CARDIOHELP-i System was not properly tested to measure leakage current
FDA · DeviceMaquet Medical Systems USANationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan,…Official notice → - 2023-12-20
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the…
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the…
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-11-15
- US
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…
Other drugs & medical recalls in the United States
- 2023-12-13
- US
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
FDA · DeviceCardioQuip, LLCUS Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IAOfficial notice → - US
Carestream Health, Inc. recalls DRX Revolution Mobile X-Ray System
Unexpected failure of electrical components within the CPI generator.
FDA · DeviceCarestream Health, Inc.Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign):…Official notice → - US
Stryker Medical Division of Stryker Corporation recalls ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
FDA · DeviceStryker Medical Division of Stryker CorporationDistribution US Nationwide including Puerto Rico, Australia, Canada, Chile,…Official notice → - US
B. Braun Medical, Inc. recalls Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming…
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy.…
- US
STAQ Pharma, Inc. recalls ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd…
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot #…
- US