FDAFDA · Food and drugs·Recall number Z-0055-2013
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Published October 17, 2012 · Recall initiated: September 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Nationwide distribution: Virginia only.
- Lot
- Part Number (Item #) AG8049-NS, Lot # 2528655.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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