Recall Z-1010-2024 ยท KRA Catheter, Continuous Flush
Angiodynamics, Inc.
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
| Date | Feb 7, 2024 (initiated Dec 18, 2023) |
| Status | Open, Classified |
| Reason | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| Root cause | Process control |
| Action | An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to complete and return the Reply Verification Tracking Form. 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 Standa |
| Quantity | 7 eaches |
| Distribution | United States (MD, LA & UT), Austria, Canada and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System AngioDynamics, Inc., May 30, 2017 |