LINEAR 7.5Fr. 40cc IAB with Accessories recall: Labeling Error
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Why was LINEAR 7.5Fr. 40cc IAB with Accessories 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
- Product
- LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
- Recalling firm
- Datascope Corporation
- Quantity
- 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.
- Recall date
- November 2, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)