6 — Class II medical device recall Z-1343-2018
Terminated recall by ICU Medical, Inc., reported 2018-04-18, distributed nationwide. The infusion sets were manufactured with an incorrect spin collar.
| Recall number | Z-1343-2018 |
|---|---|
| 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 | 2018-02-05 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 550 pouches |
| Lot numbers | 3533699, 3549590 |
| Model numbers | A1254 |
Product
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason for recall
The infusion sets were manufactured with an incorrect spin collar.
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-1343-2018. 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.