Reported Mar 22, 2023 · Terminated
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Avanos Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
- BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
- Lot codes and dates
- All lots are affected
- Stock Code (Lot Number)
B50511 (20098277)B50611 (20098278)B50711 (20098279)B50811 (2009717720097177R1)
- Amount recalled
- 220 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- OK
Why it was recalled
Stop using this product now
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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