Access 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…
Read the official notice →- Date
- 2023-10-25
- Country
- United States
- Brand
- Access Vascular
- Product
- HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IL, TX.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-05-24
USAccess 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 → - 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…
Product Mislabeled on the outer bag and inner kit Tyvek header bag
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of FL, 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
- 2023-10-25
- US
Medtronic Neuromodulation recalls SenSight Connector Plug, Model Number B31061.
Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical…
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- US
DeRoyal Industries Inc recalls DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due…
- US
Tornier, Inc recalls stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into…
- US
Cardinal Health 200, LLC recalls Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA · DeviceCardinal Health 200, LLCNationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…Official notice → - US
EITAN MEDICAL LTD recalls Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.