Extension Set recall
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection…
Why was Extension Set recalled?
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.
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): 04046964540943 Lots/Expiration Dates 61705083 31-Oct-22 61705124 31-Oct-22 61706055 31-Oct-22 61714103 31-Dec-22 61719696 31-Jan-23 61732456 31-Mar-23 61736580 31-May-23 61739427 31-May-23 61744671 31-Jul-23 61747367 31-Aug-23 61750206 31-Aug-23 61752658 30-Sep-23 61761422 30-Nov-23 61776447 30-Apr-24 61780880 30-Apr-24 61802320 30-Sep-24 61806067 31-Oct-24 61807459 31-Oct-24 61822282 28-Feb-25
- Product
- Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection…
- 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)