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
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- ZOLL Circulation
- Product
- ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Other drugs & medical recalls in the United States
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Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
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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…
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Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
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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)
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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.
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