ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling 280 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of serious harm (air embolism, blood loss) but the source text does not report any confirmed injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 280 units of the 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. The affected units are identified by Lot/UDI 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099.
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 products were distributed in the United States to California, Texas, Wisconsin, New York, North Carolina, Georgia, and Pennsylvania, as well as to Canada. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 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
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Monitoring
- Affected units
- 280
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: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099
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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Similar recalls
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