Cardiac Assist, Inc recalls SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC…
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022.…
Read the official notice →- Date
- 2023-01-25
- Country
- United States
- Brand
- Cardiac Assist
- Product
- SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Cardiac Assist recalls
- 2023-09-06
USCardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000…
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- 2022-10-05
- US
Cardiac Assist, Inc recalls TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or…
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
- 2021-12-08
- US
Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo…
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
Other drugs & medical recalls in the United States
- 2023-01-25
- US
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA · DeviceAbbott LaboratoriesUS Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WVOfficial notice → - US
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider…
FDA · DeviceMobius Imaging, LLCWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Mechanical connection between the tabletop and table base may be lost.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Armenia,…Official notice → - US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
FDA · DeviceDatascope Corp.Worldwide Distribution - US Nationwide and the countries of Albania, Angola,…Official notice → - US
Intersect ENT, Inc. recalls SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025,…
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
- US
Southwest Iowa Renewable Energy LLC recalls SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and…
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.