Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion…
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the state of…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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