Queen Comfort Products lLC recalls COVENA PICC Sleeve
Marketed without FDA clearance
Read the official notice →- Date
- 2021-11-10
- Country
- United States
- Brand
- Queen Comfort Products lLC
- Product
- COVENA PICC Sleeve
- Classification
- Class II
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2021-11-10
USFujiFilm Healthcare Americas Corporation recalls Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow…
- US
FujiFilm Healthcare Americas Corporation recalls Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement…
- US
3M Company - Health Care Business recalls 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID:…
Potential for breakage of the ECG electrode carbon stud from the eyelet.
FDA · Device3M Company - Health Care BusinessUS Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC,…Official notice → - US
Cook Inc. recalls Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath…
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in…
FDA · DeviceCook Inc.Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA.…Official notice → - US
Karl Storz Endoscopy recalls FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of…
FDA · DeviceKarl Storz EndoscopyUS: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN,…Official notice → - US
Windstone Medical Packaging, Inc. recalls Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions…
Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.