Device product
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
Z-0784-2020
Product summary
- Event
- Event 83527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115,200 pieces
- Official record key
device-enforcement:Z-0784-2020
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: 2181793, 2182007, 2182830, 2183105, 2183345(3183345), 2190034, 2190139, 2191204, 2191327
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.