3 PORT "OFF" MANIFOLD w/WASTE BAG — Class II medical device recall Z-0055-2013
Terminated recall by ICU Medical, Inc., reported 2012-10-17, distributed nationwide. ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may h
| Recall number | Z-0055-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2012-10-11 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 60 |
| Lot numbers | 2528655, K914299 |
| Model numbers | 2528655, AG8049-NS, K914299 |
Product
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0055-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.