FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
- Recall number
- Z-0663-2019
- Recalling firm
- ICU Medical, Inc.
- Product
- Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
- 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
- 25,640 units
- 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: 41424-03. Lot number (UDI) Expiration Date: 3580033 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580033) 12/1/2020; 3580037 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580037) 12/1/2020; 3580038 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580038) 12/1/2020; 3585768 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585768) 12/1/2020; 3585769 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585769) 12/1/2020; 3585770 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585770) 12/1/2020; 3585771 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585771) 12/1/2020; 3585772 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585772) 12/1/2020; 3585773 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585773) 1/1/2021; 3585774 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585774) 1/1/2021; 3585775 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585775) 1/1/2021; 3598139 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598139) 1/1/2021; 3598143 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598143) 1/1/2021; 3610803 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3610803) 1/1/2021; 3642242 ((01) 0 0840619 04414 5 (17) 210301(30) 01 (10)3642242) 3/1/2021; 3656680 ((01) 0 0840619 04414 5 (17) 210401(30) 01 (10)3656680) 4/1/2021
- 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