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Access Vascular, Inc

Complete recall history across all FDA and CPSC categories — 8 total recalls

Access Vascular, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Access Vascular, Inc

Date Product Reason Class
Aug 31, 2023 HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorre... Class II
Aug 31, 2023 HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorre... Class II
Mar 3, 2023 HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 The catheter packaged with specific lots of the HydroPICC Kits and HydroMID K... Class II
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... Label with the incorrect component listed on the inner kit Tyvek header bag Class II
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... Product Mislabeled on the outer bag and inner kit Tyvek header bag Class II
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Select catheter lots were identified to be labeled with incorrect expiration ... Class II
Dec 16, 2022 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Select catheter lots were identified to be labeled with incorrect expiration ... Class II
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Select catheter lots were identified to be labeled with incorrect expiration ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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