FDA Device recall Z-0069-2019
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 us…
- FDA Device
- Class II
- completed
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of 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 us… by Icu Medical, citing 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 awa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0069-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-08-20 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | AL, CA, FL, GA, IL, MI, MS, NC, NY, PA, UT, WA, WI |
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
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.
Identifiers
| code_info | lots: 85-540-SJ, 86-189-SL, 86-911-SJ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2019%22
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