FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
- Recall number
- Z-0661-2019
- Recalling firm
- ICU Medical, Inc.
- Product
- Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
- Status
- Terminated
- Initiated
- 2018-10-05
- Posted
- not on file
- Terminated
- 2021-03-25
- Reason
- Potential for leakage due to defect in the thermoset check valve component.
- Root cause
- Equipment maintenance
- Action
- On October 5, 2018, ICU Medical URGENT MEDCAL DEVICE RECALL letters were sent to ICU Medical's consignees advising them of this matter. Each letter contained a response form and a return label.
- Quantity
- 27,250 units total
- Distribution
- United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
- Lot, serial or model codes
- Item number:41412-01. Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611). Expiration Date 01/01/2021.
- 510(k) numbers
- ["K884318"]
- PMA numbers
- not on file
- Product code
- KRB
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28