CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Extension Set, EXT SET W/Caresite, Product recalled by B. Braun Medical
B. Braun Medical is recalling Extension Set, EXT SET W/Caresite, Product, distributed nationwide in the US. The recall was initiated on 15 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0091-2023
- FDA event ID
- 90850
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Sep 2022
- FDA classified
- 14 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 15 Sep 2022 | Recall initiated by company | |
| 14 Oct 2022 | Classified by FDA | +29 days |
| 26 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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 or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Where it was distributed
Distribution US nationwide, Canada and Saudi Arabia.
Questions about this recall
Is Extension Set, EXT SET W/Caresite, Product recalled?
Yes. B. Braun Medical recalled Extension Set, EXT SET W/Caresite, Product on 15 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0091-2023.
Why was it 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.
Which lots 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
Where was it sold?
Distribution US nationwide, Canada and Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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