Arrow International Inc recalls (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN:

Recalled April 18, 2018 · FDA recall Z-1330-2018 · Arrow International

Hazard

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

Sold at

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

Description

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

Product

(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

Manufacturer(s)

Arrow International Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →