BioFlo Midline Convenience Kits — Class II medical device recall Z-2396-2020
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-2396-2020 |
|---|---|
| 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 | 5454444, 5462690, 5463227, 5468492, 5468512, 5468514, 5469653, 5470097, 5470191, 5470195, 5470197, 5470834, 5472098, 5472104, 5472106, 5474463, 5477356, 5477373, 5477938, 5477983, 5478046, 5479479, 5480502, 5480508, 5481670, 5482399, 5486489, 5488811, 5488815, 5488819, 5488825, 5491839, 5492926, 5496906, 5497561, 5498245, 5500243, 5500249, 5501851, 5501853 and 71 more |
| Model numbers | 60M012571, 60M013354, 60M035472, 60M036708, 60M0501912, 60M0501913, 60M122029, 60M130316, 60M130318, 60M131821, 60M140891, 60M142948, 60M180343, 60M1815713, 60M220853, 60M220854, 60M250098, 60M61102511, 60M61105281, 60M61105601, 60M61109581, H96560M0125711, H96560M0133541, H96560M0354721, H96560M0367081 and 33 more |
Product
BioFlo Midline Convenience 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 H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560M611025111 H96560M611052811 H96560M611056011 H96560M611095811 H965PKM1387818S1 H965PKM1404211S1 H965PKM1635214S1 H965PKM220533S1 H965PKM220853S1 H965PKM220855S1 H965PKM61095322S1 H965PKM61102511S1 Cat. No. 60M012571 60M013354 60M035472 60M036708 60M0501912 60M0501913 60M122029 60M130316 60M130318 60M131821 60M140891 60M142948 60M180343 60M1815713 60M220853 60M220854 60M250098 60M61102511 60M61105281 60M61105601 60M61109581 PKM1387818S PKM1404211S PKM1635214S PKM220533S PKM220853S PKM220855S PKM61095322S PKM61102511S
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-2396-2020. 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.