FDAFDA · Food and drugs·Recall number Z-0786-2020
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
Published January 15, 2020 · Recall initiated: August 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intersurgical Inc
- Distributor
- US Nationwide
- Lot
- Lot numbers: 2180531, 2181808, 2182241, 2182533
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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