FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
- Recall number
- Z-1070-2019
- Recalling firm
- ICU Medical, Inc.
- Product
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
- Status
- Terminated
- Initiated
- 2018-11-27
- Posted
- not on file
- Terminated
- 2022-02-01
- Reason
- 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.
- Root cause
- Process design
- Action
- On 11/27/18, Urgent Medical Device Recall notices were sent via traceable mailing to customers informing them to discontinue use and distribution of the affected product. In addition, customers were asked to quarantine and return affected product, and to complete and return response forms. Customers were instructed to inform all potential users of the product within their organization, and if the product had been further distributed, to immediately notify these additional customers. Customers with additional questions were encouraged to call: Global Complaint Management @ 1-844-654-7780 (ProductComplaintsPP@icumed.com), Medical Information @ 1-800-241-4002 option 6 (medinfo_us@icumed.onmicrosoft.com), or Customer Care @ 1-949-366-4208.
- Quantity
- 5000
- Distribution
- U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
- Lot, serial or model codes
- Lot/UDI: 3514084/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3514084; 3550279/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3550279
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRS
- 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