Z-0784-2020 Class II Terminated
FDA device recall Z-0784-2020 was initiated by Intersurgical Inc on August 7, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 15, 2020). Affected quantity: 115,200 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2020
- Initiation Date
- August 7, 2019
- Termination Date
- December 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115,200 pieces
Product Description
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
Reason for Recall
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.
Distribution Pattern
US Nationwide
Code Information
Lot numbers: 2181793, 2182007, 2182830, 2183105, 2183345(3183345), 2190034, 2190139, 2191204, 2191327