POWERWAND XL 4Fr 8cm Maximum Barrier Kit — Class III medical device recall Z-2550-2020
Terminated recall by Access Scientific LLC, reported 2020-07-22, distributed nationwide. Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging
| Recall number | Z-2550-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Access Scientific LLC, San Diego, CA, United States |
| Recall initiated | 2020-06-15 |
| Classified | 2020-07-10 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,710 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00859821006773, 10859821006770 |
| Lot numbers | 269939, 270552, 270874, 272261 |
| Model numbers | 94108 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2550-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.