# FDA recall Z-2397-2020

> **Angiodynamics, Inc.** · Class II · device recall initiated 2020-05-04.

## Product

BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.    Item Numbers  H96560M01162101  H96560M0116291  H96560M0133531  H96560M0134211  H96560M0198811  H96560M0224741  H96560M0224751  H96560M0335621  H96560M0367041  H96560M0367051  H96560M0367061  H96560M05019111  H96560M0501981  H96560M1201961  H96560M1201971  H96560M12202101  H96560M12202111  H96560M12202121  H96560M1303151  H96560M1303171  H96560M1303191  H96560M13184101  H96560M13184111  H96560M1318491  H96560M1401411  H96560M1401421  H96560M1401431  H96560M1401441  H96560M1406061  H96560M1406071  H96560M1633931  H96560M1803441  H96560M1803451  H96560M18157111  H96560M18157121  H96560M1841151  H96560M1841161  H96560M1841171  H96560M1907131  H96560M1907141  H96560M2204

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2397-2020
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-04
- **Report date:** 2020-06-24
- **Termination date:** 2023-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2020

## Citation

> AI Analytics. FDA recall Z-2397-2020. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-2397-2020. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
