ICU Medical recall: Contamination
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush…
Why was ICU Medical recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099
- Product
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush…
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 280
- Distribution
- U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
- Recall date
- April 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)