ICU Medical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0055-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

Product Classification:

Class II

Date Initiated: September 28, 2012

Date Posted: October 17, 2012

Recall Number: Z-0055-2013

Event ID: 63362

Reason for Recall:

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.

Status: Terminated

Product Quantity: 60

Code Information:

Part Number (Item #) AG8049-NS, Lot # 2528655.

Distribution Pattern:

Nationwide distribution: Virginia only.

Voluntary or Mandated:

Voluntary: Firm initiated