Smiths Medical ASD Inc. recalls Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- Smiths Medical ASD
- Product
- Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
- Classification
- Class II
- Units
- US
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Smiths Medical ASD recalls
- 2024-02-07
USSmiths Medical ASD Inc. recalls smiths medical Medfusion Model 3500 Syringe pump
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4.…
- 2024-01-24
- US
Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during…
FDA · DeviceSmiths Medical Asd IncWorldwide distribution - US Nationwide and the countries of Canada, UAE.Official notice → - 2023-11-08
- US
Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
FDA · DeviceSmiths Medical ASD Inc.Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH,…Official notice → - 2023-10-18
- US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-09-06
- US
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- 2023-05-24
- US
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the countries of Canada, New…Official notice →
Other drugs & medical recalls in the United States
- 2023-11-01
- US
Preat Corp recalls Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- US
Cardinal Health 200, LLC recalls Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID,…Official notice → - US
GE Healthcare recalls Universal Viewer Workflow Manager, Image processing radiological system
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and…
FDA · DeviceGE HealthcareNationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO,…Official notice → - US
GE Healthcare recalls Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and…
FDA · DeviceGE HealthcareUS and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile,…Official notice → - US
Maquet Cardiovascular, LLC recalls Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy…
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural…
FDA · DeviceMaquet Cardiovascular, LLCNationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TROfficial notice → - US
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and…
FDA · DeviceAcclarent, Inc.US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME,…Official notice →