Datascope Corporation Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr
Datascope Corporation Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Datascope Corporation; Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 068
| Recalling firm | Datascope Corporation |
|---|---|
| Product | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. |
| Reason for recall | Potential Endotoxin Contamination |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, S |
| Recall initiated | 20200727 |
| Recall number | Z-2839-2020 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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