Is ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets recalled?

Question

Is ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton.  to provide needle-free access on I.V. and Extension Sets recalled?

Accepted Answer

Recall reasons:
• The extension set has a high probability of  failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications.  Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
• The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications.  Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
• The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications.  Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

Status: Voluntary: Firm initiated

Initial Firm Notification: Letter

Distribution: Distribution US nationwide, Canada and Saudi Arabia.

Affected Products

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Affected Products

Additional Information

Were You Affected by This Recall?