Device recall: HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Class II FDA enforcement event 93043. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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 adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Access Vascular, Inc started this device recall on 31 Aug 2023. The firm address in the FDA record is in Billerica, MA. FDA put the recall in Class II. FDA event 93043 has 2 product records. The first FDA enforcement report date is 25 Oct 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of IL, TX.
Recalling firm
Access Vascular, Inc, Billerica, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0114-2024 | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 | 58 total | Class II | Ongoing | 25 Oct 2023 |
| Z-0115-2024 | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | 58 total | Class II | Ongoing | 25 Oct 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Mar 2023 | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | Device | Class II | 1 |
| 22 Dec 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access | Device | Class II | 1 |
| 22 Dec 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access | Device | Class II | 1 |
| 16 Dec 2022 | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | Device | Class II | 3 |
| 24 Feb 2021 | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0114-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93043. https://recallregister.com/fda/ii/93043/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of IL, TX.
- What quantity of product is in FDA event 93043?
- The event has 2 product records. The first record gives this quantity:
58 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.