CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- CardioQuip
- Product
- CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AK, AL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 CardioQuip recalls
- 2023-12-27
USCardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA · DeviceCardioQuip, LLCUS: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: NoneOfficial notice →- 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 → - 2021-10-13
- US
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating…
FDA · DeviceCardioQuip, LLCWorldwide distribution - US Nationwide distribution including in the states of…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-13
- US
Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
FDA · DevicePhilips Ultrasound IncWorldwide distribution - US Nationwide distribution in the states of CA, MA,…Official notice → - US
CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating…
FDA · DeviceCardioQuip, LLCWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
ZOLL Circulation, Inc. recalls ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
FDA · DeviceZOLL Circulation, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
Flower Orthopedics Corporation recalls Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
FDA · DeviceFlower Orthopedics CorporationUS Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY,…Official notice → - US
Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP…
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
FDA · DeviceSentinel CH SpAUS Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto…Official notice → - US
Beckman Coulter Inc. recalls Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover…
FDA · DeviceBeckman Coulter Inc.U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS,…Official notice →