CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Powerport ClearVUE Slim with Smooth Septum recalled
Bard Peripheral Vascular is recalling Powerport ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, 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-1768-2018
- 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 Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Where it was distributed
Nationwide
Questions about this recall
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) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052
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 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
13 other products · FDA event 79841This product is part of a recall event; the main page for the event is Powerport ClearVUE isp with Smooth Septum, 6F ChronoFlex recalled.
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| Device | CLASS II | Venclose digiRF Generators recalled by Bard Peripheral Vascular | Bard Peripheral Vascular | Temperature Abuse | Nationwide |
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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |