PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1
FDA device recall Z-1010-2024 · posted 2024-02-07 · Open, Classified
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- Action taken
- 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 Standard Time) to obtain a replacement or credit for your returned product.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KRA
- Quantity affected
- 7 eaches
- Distribution
- United States (MD, LA & UT), Austria, Canada and Spain.
- Date initiated
- 2023-12-18
- Date posted
- 2024-02-07
- Location
- Queensbury, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Pulse* Spray Infusion System, Uni*Fuse Infusion System (K163356) | AngioDynamics, Inc. | 2017-05-30 |