FDA Device recall Z-0055-2013
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655 by Icu Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0055-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-28 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
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.
Identifiers
| code_info | Part Number (Item #) AG8049-NS, Lot # 2528655. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0055-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.