FDA recall Z-1327-2018

Arrow International Inc · Class II · device

Product

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Distribution

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Key facts

Status
Terminated
Initiation date
2017-12-22
Report date
2018-04-18
Termination date
2020-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2018