Recall Z-2397-2020 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics, Inc.
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are 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. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H9
| Date | May 4, 2020 |
| Status | Terminated |
| Reason | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. |
| Root cause | Process control |
| Action | The firm distributed URGENT VOLUNTARY MEDICAL DEVICE RECALL letters to affected customers on May 4, 2020. Customers were instructed to segregate and return affected devices to AngioDynamics, and to complete and return the reply verification tracking form provided with the recall notification. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. The letter included instructions on packaging and returni |
| Quantity | 119723 eaches total |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.