FDA-Device2018-04-18Class II
(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
Arrow International Inc
Hazard
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Sold states
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
(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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2018Don't want to check this manually?
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