FDA Device recall Z-2395-2020
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of di…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of di… by Angiodynamics, citing certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2395-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-04 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics |
| Distribution | US |
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
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Identifiers
| code_info | Lots 5478035 5530253 5583183* 5462686 5468487 5487198 5505544 5519248 5526065 5530262 5534809 5536989 55464…Lots 5478035 5530253 5583183* 5462686 5468487 5487198 5505544 5519248 5526065 5530262 5534809 5536989 5546450 5567428 5569508 5571868 5576312 5583181 5501024 5501025 5564647 5488838 5478041 5585510* 5585511* 5587219* 5552115* 5478044 5530251 5559242 5585515* 5465969 5474443 5482393 5504961 5513039 5526056 5530254 5534816 5544027 5555083 5574390 5580534 5583184 5462685 5561894 5498181 5566253 5587224* 5519243 5583179* 5585513* 5587221* 5496953 5498175* 5534818* 5589118* 5513035* 5498169 5536984* 5585512* 5589119* 5513036 5474195 5474196 5528626 5496961 5494432 5505549 5546447* 5498170* 5538017* 5474199 5494439 5500300* 5532465* 5460241 5480530 5491810 5513040 5528628 5538007 5548525 5567430 5460240 5465961 5465962 5468486 5470188 5470190 5474448 5478037 5478038 5482386 5482387 5482388 5485167 5485168 5487202 5487203 5488833 5502090 5502091 5504971 5505552 5513042 5513043 5513044 5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2395-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.