Medtronic Bio-Medicus Insertion Kits recall: Labeling Error
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Why was Medtronic Bio-Medicus Insertion Kits recalled?
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
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?
Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
- Product
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 168 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)