CLASS II ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
Duramax Stacked Tip Straight Vasc-pak recalled by Angiodynamics
Angiodynamics is recalling Duramax Stacked Tip Straight Vasc-pak, 5-UP PG- Indicated for use in attaining Long-Term, distributed in Virginia. The recall was initiated on 18 Mar 2024 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-1772-2024
- FDA event ID
- 94349
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2024
- FDA classified
- 3 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 18 Mar 2024 | Recall initiated by company | |
| 3 May 2024 | Classified by FDA | +46 days |
| 15 May 2024 | 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
XXX
Product as listed by the FDA
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
Where it was distributed
VA
Questions about this recall
Why was it recalled?
XXX
Which lots are affected?
UDI-DI: 25051684011935 Lot Numbers: 5807195, 5807196
Where was it sold?
VA
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
14 other products · FDA event 94349This product is part of a recall event; the main page for the event is Duraflow 2 Straight Basic Kit Pg-Indicated for use recalled.
More recalls from Angiodynamics
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|---|---|---|---|---|---|
| Device | CLASS II | Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |