FDA recall Z-0785-2020

Product

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. 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-0785-2020