CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Powerport ClearVUE isp with Smooth Septum, 8F ChronoFlex recalled
Bard Peripheral Vascular is recalling Powerport ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, distributed nationwide in the US. The recall was initiated on 8 Feb 2018 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-1761-2018
- FDA event ID
- 79841
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 8 Feb 2018
- FDA classified
- 9 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 8 Feb 2018 | Recall initiated by company | |
| 9 May 2018 | Classified by FDA | +90 days |
| 16 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Where it was distributed
Nationwide
Questions about this recall
Is Powerport ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter recalled?
Yes. Bard Peripheral Vascular recalled Powerport ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter on 8 Feb 2018. The recall is Class II and its status is Completed. Recall number Z-1761-2018.
Why was it recalled?
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Which lots are affected?
Lot Number Unique Device Identifier (UDI) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758
Where was it sold?
Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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