FDA recall Z-2397-2020

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

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

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