FDA Device recall Z-2841-2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use:…
- FDA Device
- Class II
- ongoing
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use:… by Datascope, citing potential Endotoxin Contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2841-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-27 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Datascope |
| Distribution | US |
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Reason
Potential Endotoxin Contamination
Identifiers
| code_info | Kit Lot Number: 3000066986 3000069732 3000077731 3000077732 3000080305 3000083332 3000083333 3000084968 30000…Kit Lot Number: 3000066986 3000069732 3000077731 3000077732 3000080305 3000083332 3000083333 3000084968 3000087492 3000095469 3000096180 3000096181 3000096585 3000098052 3000103498 3000104616 3000104617 3000112275 3000113067 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2841-2020%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.