FDA recall Z-1333-2018

Product

ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A

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-1333-2018