Datascope Corporation Recall: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 068
Datascope Corporation Recall: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 068 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Datascope Corporation; Product: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.; Reason fo
| Recalling firm | Datascope Corporation |
|---|---|
| Product | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. |
| Reason for recall | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay. |
| Recall initiated | 20220805 |
| Recall number | Z-0131-2023 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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