IMPERATIVE CARE INC recalls Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx…
There is a potential for distal end of catheters to fracture and become detached.
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- IMPERATIVE CARE INC
- Product
- Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx…
- Classification
- Class I
- Units
- US nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2021-10-06
US
North Coast Medical Inc recalls EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe…
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
FDA · DeviceNorth Coast Medical IncWorldwide distribution. US nationwide, Canada, Israel, South Africa,…Official notice →US
Biodex Medical Systems, Inc. recalls Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an…
FDA · DeviceBiodex Medical Systems, Inc.Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia…Official notice →US
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, MI, NY, TX, WI.Official notice →US
Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/…
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →US
Medline Industries Inc recalls NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only,…
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
FDA · DeviceMedline Industries IncWorldwide distribution - US Nationwide distribution and the countries of…Official notice →US
Olympus Corporation of the Americas recalls BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Product also distributed globally.Official notice →