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.
Read the official notice →- Date
- 2022-10-05
- Country
- United States
- Brand
- Cardiac Assist
- Product
- TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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,
- 2023-01-25
- US
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.…
- 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
- 2022-10-05
- US
SunMed Holdings, LLC recalls Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
FDA · DeviceSunMed Holdings, LLCDomestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.Official notice → - US
Howmedica Osteonics Corp. recalls Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the…
FDA · DeviceHowmedica Osteonics Corp.Distributed to one customer located in New York.Official notice → - US
Collagen Matrix Inc recalls Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast…
The packaging may not be sealed, which could compromise sterility.
FDA · DeviceCollagen Matrix IncUS distribution to distributors in IL, IN, MI, NC, OH, and TXOfficial notice → - US
MALVERN PANALYTICAL LTD recalls NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Product found to not comply to Class 1 Laser safety requirement.
- US
bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Invalid calibrations (out of range high) while using the product.
FDA · DevicebioMerieux, Inc.Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH,…Official notice → - US
ALMIRALL, LLC recalls Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity