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Terminated

BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016-NP 46-017 46-018 46-022 46-023 46-024 46-025 46-026 46-027 46-028 46-029 46-460 46-470 46-480 46-490

FDA Recall Z-2395-2020 · Posted None

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2020-05-04
Date Terminated2023-08-23
Product Quantity119723 eaches total

Reason for Recall

Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

Firm 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 returning the recalled product.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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