FDA recall Z-0786-2020

Intersurgical Inc · Class II · device

Product

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. 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

US Nationwide

Key facts

Status
Terminated
Initiation date
2019-08-07
Report date
2020-01-15
Termination date
2020-12-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2020