Datascope Corporation 2022-11-02 Health serious FDA
Health · FDA · Recall #FDA-Z-0131-2023
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic… Recall
Issued November 2, 2022 · Datascope Corporation
In November 2022, Datascope Corporation recalled the LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Datascope Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Datascope Corporation
- Category
- Health
- Recall date
- November 2, 2022
- Units affected
- Not reported
- Sold at
- No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jo
- Recall number
- FDA-Z-0131-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Datascope Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.