ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk
ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly lists 'air embolism' and 'blood loss' as potential consequences, which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.
Plain-English summary
ICU Medical, Inc. is recalling 5,000 units of the 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. The affected lots are 3514084 and 3550279. These products were distributed in the United States (California, Texas, Wisconsin, New York, North Carolina, Georgia, Pennsylvania) and Canada.
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.
Healthcare facilities and consumers should stop using the affected products immediately and contact ICU Medical, Inc. for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 5,000
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 (2)
- 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
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.
See all 3 products in this recall →Related recalls
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