ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury, including air embolism and blood loss, which aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Transpac IV Monitoring Kits with Safeset Reservoir and Blood Sampling Port. The affected product is a sterile, ethylene oxide-sterilized kit featuring 60-inch tubing, a disposable transducer, and a 3 ml Intraflo Flush, identified by Reference 42641-06.
The recall is due to reports of pressure tubing separation between the sampling port and the high-pressure tubing. This defect could lead to a delay in therapy. In rare circumstances, the separation could result in blood loss, air embolism, or contamination of the fluid path.
The affected units were distributed in the United States to California, Texas, Wisconsin, New York, North Carolina, Georgia, Pennsylvania, and New York, as well as in Canada. Healthcare facilities and consumers should check their inventory for the specific lot number 3529857 and stop using the product if it matches the recall description.
The recalled product
- Product
- ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Monitoring
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/UDI: 3529857/ (01)0 0840619 04495 4 (17) 200901 (30) 01 (10) 3529857
Distribution
Part of a larger recall action
This product is one of 3 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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