Z-0787-2020 Class II Terminated

Recalled by Intersurgical Inc — East Syracuse, NY

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
50,400 pieces

Product Description

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. 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: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591