FDA-Device2018-04-18Class II
(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
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) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1323-2018Don't want to check this manually?
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