FDA Device recall Z-2550-2020
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalo…
- FDA Device
- Class III
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class III recall of POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalo… by Access Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2550-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-15 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Access Scientific |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot number 269939, 270552, 270874, and 272261. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2550-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.