BioFlo Midline Catheter and BioFlo Maximal Barrier Kits — Class II medical device recall Z-2395-2020
Terminated recall by Angiodynamics, Inc., reported 2020-06-24, distributed nationwide. Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medica
| Recall number | Z-2395-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2020-05-04 |
| Classified | 2020-06-17 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 119,723 eaches |
| Lot numbers | 5459121, 5460240, 5460241, 5462681, 5462682, 5462685, 5462686, 5465961, 5465962, 5465963, 5465964, 5465969, 5468482, 5468483, 5468485, 5468486, 5468487, 5470188, 5470189, 5470190, 5472092, 5472093, 5474195, 5474196, 5474199, 5474443, 5474448, 5478035, 5478037, 5478038, 5478041, 5478044, 5480530, 5480534, 5480535, 5482386, 5482387, 5482388, 5482390, 5482393 and 148 more |
| Model numbers | 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, H965460151, H965460161, H965460161-NP, H965460171, H965460181, H965460221, H965460231, H965460241 and 10 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2395-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.