Z-0092-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 354,200 US; 1,800 OUS
Product Description
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide, Canada and Saudi Arabia.
Code Information
UDI-DI (GTIN): 04046964298691 Lots/Expiration Dates 61762215 15-Dec-23 61762791 22-Jan-24 61767369 26-Feb-24 61779625 7-Jun-24 61791895 11-Aug-24 61806047 4-Nov-24