143" — Class II medical device recall Z-2648-2018
Terminated recall by ICU Medical, Inc., reported 2018-08-15, distributed nationwide. Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
| Recall number | Z-2648-2018 |
|---|---|
| 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 | 2017-07-31 |
| Classified | 2018-08-07 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CY, JP, KW, MY, ZA |
| Quantity | 160,016 units |
| Reason classes | labeling |
| Lot numbers | 69-338-SJ, 72-415-HE |
| Model numbers | Z2819 |
Product
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Reason for recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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-2648-2018. 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.