PlainRecalls
FDA Devices Moderate Class II 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

Reported: June 24, 2020 Initiated: May 4, 2020 #Z-2395-2020

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Angiodynamics, Inc.
Units Affected
119723 eaches total
Distribution
US Nationwide distribution.
Location
Queensbury, NY

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Angiodynamics, Inc.. Units affected: 119723 eaches total.
Why was this product recalled? ▼
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2395-2020.

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