Z-1071-2019 Class II Terminated
FDA device recall Z-1071-2019 was initiated by ICU Medical, Inc. on Nov 27, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Feb 1, 2022). Affected quantity: 280.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2019
- Initiation Date
- Nov 27, 2018
- Termination Date
- Feb 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280
Product Description
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
Reason for Recall
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.
Distribution Pattern
U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
Code Information
Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1071-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026