LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Reported: November 2, 2022 Initiated: August 5, 2022 #Z-0131-2023
Product Description
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.
Details
- Recalling Firm
- Datascope Corporation
- Units Affected
- 4414 OUS
- 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.
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.. Recalled by Datascope Corporation. Units affected: 4414 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0131-2023.
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