ICU Medical — Class II medical device recall Z-1072-2019
Terminated recall by ICU Medical, Inc., reported 2019-04-03, distributed in CA, GA, NC, NY, PA, TX, WI. Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots o
| Recall number | Z-1072-2019 |
|---|---|
| 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 | 2018-11-27 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2022-02-01 |
| Distributed | CA, GA, NC, NY, PA, TX, WI |
| Countries outside the US | CA |
| Model numbers | 42641-06 |
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Reason for recall
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
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-1072-2019. 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.