Caresite Smallbore EXT SET T-port 5 in recall
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…
Why was Caresite Smallbore EXT SET T-port 5 in recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 354,200 US; 1,800 OUS
- Distribution
- Distribution US nationwide, Canada and Saudi Arabia.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)