Recall Z-2617-2021— Angiodynamics Inc. (Navilyst Medical Inc.)
Class II · Terminated
Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2017-10-17, terminated 2022-06-14. FDA's recall record names no specific 510(k) clearance for this event. 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 venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995. Reason: 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)..
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-17
- Terminated
- 2022-06-14
- Firm location
- Glens Falls, NY, United States
Product description
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 venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.