CLASS III Device recall · Reported 22 Jul 2020 · FDA Enforcement Report
Powerwand XL Maximum Barrier Kit (Introducer recalled
Access Scientific is recalling Powerwand XL Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of, distributed nationwide in the US. The recall was initiated on 15 Jun 2020 and the FDA has classified it as Class III.
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-2550-2020
- FDA event ID
- 85808
- Recalling firm
- Access Scientific, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Jun 2020
- FDA classified
- 10 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 15 Jun 2020 | Recall initiated by company | |
| 10 Jul 2020 | Classified by FDA | +25 days |
| 22 Jul 2020 | 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
Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
Product as listed by the FDA
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.
Where it was distributed
US Nationwide distribution including in the state of NY.
Questions about this recall
Is Powerwand XL Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of recalled?
Yes. Access Scientific recalled Powerwand XL Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of on 15 Jun 2020. The recall is Class III and its status is Terminated. Recall number Z-2550-2020.
Why was it recalled?
Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
Which lots are affected?
Lot number 269939, 270552, 270874, and 272261.
Where was it sold?
US Nationwide distribution including in the state of NY.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used recalled by Access Scientific | Access Scientific | Sterility | Nationwide |
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| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used recalled by Access Scientific | Access Scientific | Sterility | Nationwide |
| Device | CLASS II | BD PosiFlush SF Saline Flush Syringe used in Powerwand XL Quick Kit recalled | Access Scientific | Sterility | Nationwide |
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