CLASS II ONGOING Device recall · Reported 25 Oct 2023 · FDA Enforcement Report
HydroPICC Dual Lumen Maximal Barrier Kit, Product recalled
Access Vascular is recalling HydroPICC Dual Lumen Maximal Barrier Kit, Product, distributed nationwide in the US. The recall was initiated on 31 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0115-2024
- FDA event ID
- 93043
- Recalling firm
- Access Vascular, Billerica, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2023
- FDA classified
- 13 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2023 | Recall initiated by company | |
| 13 Oct 2023 | Classified by FDA | +43 days |
| 25 Oct 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Where it was distributed
US Nationwide distribution in the states of IL, TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00850030354068; Lot Number: 11469666
Where was it sold?
US Nationwide distribution in the states of IL, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93043This product is part of a recall event; the main page for the event is HydroPICC Dual Lumen guidewire - Basic Kit, Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HydroPICC Dual Lumen guidewire - Basic Kit, Product recalled | Access Vascular | Other | Nationwide |
More recalls from Access Vascular
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HydroPICC Dual Lumen guidewire - Basic Kit, Product recalled | Access Vascular | Other | Nationwide |
| Device | CLASS II | HydroPICC Single Lumen Catheter, Maximal Barrier Kit recalled | Access Vascular | Packaging Defects | FL, TN, TX |
| Device | CLASS II | HydroMID Single Lumen Maximal Barrier Kit-indicated recalled | Access Vascular | Other | Nationwide |
| Device | CLASS II | HydroMID Single Lumen Maximal Barrier Kit- Indicated recalled | Access Vascular | Labeling Errors | Nationwide |
| Device | CLASS II | HydroPICC Single Lumen Guidewire - Basic Kit recalled by Access Vascular | Access Vascular | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |