FDA-Device2012-10-17Class II
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
ICU Medical, Inc.
Hazard
ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
Sold states
Nationwide distribution: Virginia only.
Affected count
60
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0055-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief