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Arrow International Inc recalls (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization
Recalled April 18, 2018 · FDA recall Z-1331-2018 · 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
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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) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →