ICU Medical 14" — Class II medical device recall Z-0069-2019
Completed recall by ICU Medical, Inc., reported 2018-10-10, distributed in AL, CA, FL, GA, IL, MI, MS, NC…. Design change implemented changing the device from a blood set with a filter to a transfer set without a filte
| Recall number | Z-0069-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2018-08-20 |
| Classified | 2018-10-04 |
| Reported by FDA | 2018-10-10 |
| Distributed | AL, CA, FL, GA, IL, MI, MS, NC, NY, PA, UT, WA, WI |
| Quantity | 2,361 units |
| Lot numbers | 85-540-SJ, 86-189-SL, 86-911-SJ |
| Model numbers | 14237-28 |
Product
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
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-0069-2019. 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.