Xcela PICC with PASV Valve Technology/Kit 5 F-55cm recall: Labeling Error
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central…
Why was Xcela PICC with PASV Valve Technology/Kit 5 F-55cm recalled?
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot Number: 5210162 (UDI): H96560M7019951
- Product
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central…
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- 4 boxes (5/each)= 20 eaches
- Distribution
- Canada
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)