Class II — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system. |
| Quantity | 60 |
| Distribution | Nationwide distribution: Virginia only. |
| Initiated | 2012-09-28 |
| Classified | 2012-10-11 |
| Terminated | 2013-02-19 |
| Recall number | Z-0055-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ICU Medical, Inc. (Z-0055-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63362/
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