FDA Devices recall · Reported June 24, 2020
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 H96560
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Angiodynamics, Inc. recalled BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percu… - a moderate-severity action.
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percu… was recalled by Angiodynamics, Inc. in June 24, 2020. Reason: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medic…. Check the official notice for the remedy. Verify recall #Z-2396-2020 with the FDA Devices before acting.
The recall
Angiodynamics, Inc. issued this moderate-severity FDA Devices recall-Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medic….
- Moderate
- severity level
- Class II
- classification
- June 24, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2396-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2396-2020 |
| Date reported | June 24, 2020 |
| Date initiated | May 4, 2020 |
| Recalling firm | Angiodynamics, Inc. |
| Firm location | Queensbury, NY |
| Affected scope | 119723 eaches total |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2396-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026