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Access Vascular, Inc FDA Recalls
9 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004Class IIAug 31, 2023Specific lots of the Dual Lumen HydroPICC Kits were provided |
| HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002Class IIAug 31, 2023Specific lots of the Dual Lumen HydroPICC Kits were provided |
| HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004Class IIMar 3, 2023The catheter packaged with specific lots of the HydroPICC Ki |
| HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous accesClass IIDec 22, 2022Label with the incorrect component listed on the inner kit T |
| HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous acceClass IIDec 22, 2022Product Mislabeled on the outer bag and inner kit Tyvek head |
| HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001Class IIDec 16, 2022Select catheter lots were identified to be labeled with inco |
| HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002Class IIDec 16, 2022Select catheter lots were identified to be labeled with inco |
| HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002Class IIDec 16, 2022Select catheter lots were identified to be labeled with inco |
| Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central CatheterClass IIFeb 24, 2021Scalpel and StatLock components packaged with specific lots |