Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for…
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Read the official notice →- Date
- 2023-03-01
- Country
- United States
- Brand
- Access Vascular
- Product
- HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, TX, WA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Access Vascular recalls
- 2023-10-25
USAccess Vascular, Inc recalls HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for…
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of IL, TX.Official notice →- 2023-05-24
- US
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
- 2023-03-01
- US
Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for…
Label with the incorrect component listed on the inner kit Tyvek header bag
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.Official notice → - 2023-02-22
- US
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.Official notice → - 2022-11-16
- US
Access Vascular, Inc. recalls Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
FDA · DeviceAccess Vascular, Inc.Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.Official notice →
Other drugs & medical recalls in the United States
- 2023-03-01
- US
S & MOHR AMERICA, S.A. DE C.V. recalls abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing…
Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"
FDA · DeviceS & MOHR AMERICA, S.A. DE C.V.U.S. Nationwide distribution in the state of MN.Official notice → - US
Cardinal Health 200, LLC recalls Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of GA, PA.Official notice → - US
Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for…
Label with the incorrect component listed on the inner kit Tyvek header bag
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and…
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿…Official notice → - US
Hologic, Inc. recalls Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D…
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection…
Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide distribution in the states of GA, UT.Official notice →