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Recall Observatory FDA recall evidence

Device product

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

Z-0055-2013

September 28, 2012

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 63362
Status
Terminated
Classification
Class II
Quantity
60
Official record key
device-enforcement:Z-0055-2013

Official wording

Reason: 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.

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

Distribution pattern: Nationwide distribution: Virginia only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.