Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1010-2024 — 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.

U.S. FDA — Device Enforcement · United States · 2023-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1010-2024
Date of alert
2023-12-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15051684013109
Reported risk: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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