Device product
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Z-0787-2020
Product summary
- Event
- Event 83527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,400 pieces
- Official record key
device-enforcement:Z-0787-2020
Official wording
Reason: 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.
Code information: Lot numbers: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.